LABELS · f0963394-1070-4d0d-977b-280e888b626b

Miacalcin

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2024-04-15
Captured: 2026-09-09T23:38:04.335995+00:00
Current indication reconciliation: Not reconciled

Indications and usage: exact source text

1 INDICATIONS AND USAGE Miacalcin synthetic injection is a calcitonin, indicated for the following conditions: • Treatment of symptomatic Paget’s disease of bone when alternative treatments are not suitable ( 1.1 ) • Treatment of hypercalcemia ( 1.2 ) • Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated ( 1.3 ) Limitations of Use: • Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis ( 1.4 , 5.3 ) 1.1 Treatment of Paget’s Disease of Bone Miacalcin injection is indicated for the treatment of symptomatic Paget’s disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. There is no evidence that the prophylactic use of calcitonin salmon is beneficial in asymptomatic patients. Miacalcin injection should be used only in patients who do not respond to alternative treatments or for whom such treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). 1.2 Treatment of Hypercalcemia Miacalcin injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents. 1.3 Treatment of Postmenopausal Osteoporosis Miacalcin injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. The evidence of efficacy for calcitonin salmon injection is based on increases in total body calcium observed in clinical trials. Fracture reduction efficacy has not been demonstrated. Miacalcin injection should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). 1.4 Important Limitations of Use Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis [see Warnings and Precautions (5.3) ] .

Full extracted label fields

application numbers

NDA017808

boxed warning exact

brand names

Miacalcin

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89cd4f46-b88a-4c10-b25c-47352280dc4e

generic names

CALCITONIN SALMON

f0963394-1070-4d0d-977b-280e888b626b

indications and usage exact

1 INDICATIONS AND USAGE Miacalcin synthetic injection is a calcitonin, indicated for the following conditions: • Treatment of symptomatic Paget’s disease of bone when alternative treatments are not suitable ( 1.1 ) • Treatment of hypercalcemia ( 1.2 ) • Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated ( 1.3 ) Limitations of Use: • Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis ( 1.4 , 5.3 ) 1.1 Treatment of Paget’s Disease of Bone Miacalcin injection is indicated for the treatment of symptomatic Paget’s disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. There is no evidence that the prophylactic use of calcitonin salmon is beneficial in asymptomatic patients. Miacalcin injection should be used only in patients who do not respond to alternative treatments or for whom such treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). 1.2 Treatment of Hypercalcemia Miacalcin injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents. 1.3 Treatment of Postmenopausal Osteoporosis Miacalcin injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. The evidence of efficacy for calcitonin salmon injection is based on increases in total body calcium observed in clinical trials. Fracture reduction efficacy has not been demonstrated. Miacalcin injection should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). 1.4 Important Limitations of Use Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis [see Warnings and Precautions (5.3) ] .

indications and usage tables exact

is original packager

true

manufacturer names

Mylan Institutional LLC

matched search terms

malignancy

package ndcs

67457-675-02

product ndcs

67457-675

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAMUSCULAR
SUBCUTANEOUS

rxcuis

213570
308866

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00800.json

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · indication intro context

application numbers

NDA017808

brand names

Miacalcin

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement
incomplete_colon_led_indication_intro

clinical review status

pending

content role

indication_intro_context

context span

end: 310
end exclusive: true
exact text: 1 INDICATIONS AND USAGE Miacalcin synthetic injection is a calcitonin, indicated for the following conditions: • Treatment of symptomatic Paget’s disease of bone when alternative treatments are not suitable ( 1.1 ) • Treatment of hypercalcemia ( 1.2 ) • Treatment of postmenopausal osteoporosis when alternativ
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 0

current approval status

not_reconciled

duplicate text group

dup-7478e0b06259d1f0e444

extraction review status

automated_candidate_pending_source_review

generic names

CALCITONIN SALMON

ind-span-1d59f071818bb0a568bf

label id

f0963394-1070-4d0d-977b-280e888b626b

positive predicate support span

end: 80
end exclusive: true
exact text: is a calcitonin, indicated
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 54

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7

source defined aliases

source span

end: 110
end exclusive: true
exact text: 1 INDICATIONS AND USAGE Miacalcin synthetic injection is a calcitonin, indicated for the following conditions:
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22f0963394-1070-4d0d-977b-280e888b626b%22

spl effective date

2024-04-15

spl set id

89cd4f46-b88a-4c10-b25c-47352280dc4e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 2 · unclassified context

application numbers

NDA017808

brand names

Miacalcin

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 414
end exclusive: true
exact text: 1 INDICATIONS AND USAGE Miacalcin synthetic injection is a calcitonin, indicated for the following conditions: • Treatment of symptomatic Paget’s disease of bone when alternative treatments are not suitable ( 1.1 ) • Treatment of hypercalcemia ( 1.2 ) • Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated ( 1.3 ) Limitations
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 0

current approval status

not_reconciled

duplicate text group

dup-ac1019683f7184ac8547

extraction review status

automated_candidate_pending_source_review

generic names

CALCITONIN SALMON

ind-span-46ffe4be9b366e6b1352

label id

f0963394-1070-4d0d-977b-280e888b626b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7

source defined aliases

source span

end: 214
end exclusive: true
exact text: • Treatment of symptomatic Paget’s disease of bone when alternative treatments are not suitable ( 1.1 )
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 111

source url

https://api.fda.gov/drug/label.json?search=id%3A%22f0963394-1070-4d0d-977b-280e888b626b%22

spl effective date

2024-04-15

spl set id

89cd4f46-b88a-4c10-b25c-47352280dc4e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 3 · unclassified context

application numbers

NDA017808

brand names

Miacalcin

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 451
end exclusive: true
exact text: ND USAGE Miacalcin synthetic injection is a calcitonin, indicated for the following conditions: • Treatment of symptomatic Paget’s disease of bone when alternative treatments are not suitable ( 1.1 ) • Treatment of hypercalcemia ( 1.2 ) • Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated ( 1.3 ) Limitations of Use: • Due to the possible associ
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 15

current approval status

not_reconciled

duplicate text group

dup-fda844c98afc8839ce06

extraction review status

automated_candidate_pending_source_review

generic names

CALCITONIN SALMON

ind-span-431ba2ec3e65b3c78e10

label id

f0963394-1070-4d0d-977b-280e888b626b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7

source defined aliases

source span

end: 251
end exclusive: true
exact text: • Treatment of hypercalcemia ( 1.2 )
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 215

source url

https://api.fda.gov/drug/label.json?search=id%3A%22f0963394-1070-4d0d-977b-280e888b626b%22

spl effective date

2024-04-15

spl set id

89cd4f46-b88a-4c10-b25c-47352280dc4e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 4 · unclassified context

application numbers

NDA017808

brand names

Miacalcin

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 540
end exclusive: true
exact text: n is a calcitonin, indicated for the following conditions: • Treatment of symptomatic Paget’s disease of bone when alternative treatments are not suitable ( 1.1 ) • Treatment of hypercalcemia ( 1.2 ) • Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated ( 1.3 ) Limitations of Use: • Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 52

current approval status

not_reconciled

duplicate text group

dup-b527d3623697cc332e16

extraction review status

automated_candidate_pending_source_review

generic names

CALCITONIN SALMON

ind-span-9ad1ccaaa38724ff892f

label id

f0963394-1070-4d0d-977b-280e888b626b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7

source defined aliases

source span

end: 340
end exclusive: true
exact text: • Treatment of postmenopausal osteoporosis when alternative treatments are not suitable.
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 252

source url

https://api.fda.gov/drug/label.json?search=id%3A%22f0963394-1070-4d0d-977b-280e888b626b%22

spl effective date

2024-04-15

spl set id

89cd4f46-b88a-4c10-b25c-47352280dc4e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 5 · limitation of use

application numbers

NDA017808

brand names

Miacalcin

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 622
end exclusive: true
exact text: et’s disease of bone when alternative treatments are not suitable ( 1.1 ) • Treatment of hypercalcemia ( 1.2 ) • Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated ( 1.3 ) Limitations of Use: • Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis ( 1.4 , 5.3 ) 1.1 Treatment of Paget’s Diseas
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 141

current approval status

not_reconciled

duplicate text group

dup-04b02b0757500d1cc679

extraction review status

automated_candidate_pending_source_review

generic names

CALCITONIN SALMON

ind-span-ef29980612f7d036e3a7

label id

f0963394-1070-4d0d-977b-280e888b626b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7

source defined aliases

source span

end: 422
end exclusive: true
exact text: Fracture reduction efficacy has not been demonstrated ( 1.3 ) Limitations of Use:
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 341

source url

https://api.fda.gov/drug/label.json?search=id%3A%22f0963394-1070-4d0d-977b-280e888b626b%22

spl effective date

2024-04-15

spl set id

89cd4f46-b88a-4c10-b25c-47352280dc4e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 6 · unclassified context

application numbers

NDA017808

brand names

Miacalcin

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 790
end exclusive: true
exact text: ent of hypercalcemia ( 1.2 ) • Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated ( 1.3 ) Limitations of Use: • Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis ( 1.4 , 5.3 ) 1.1 Treatment of Paget’s Disease of Bone Miacalcin injection is indicated for the treatment of symptomatic Paget’s disease of bone in patients with moderate to severe disease characterized by polyost
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 223

current approval status

not_reconciled

duplicate text group

dup-c78fd9a70518b7c6eff8

extraction review status

automated_candidate_pending_source_review

generic names

CALCITONIN SALMON

ind-span-8036af8fd976967496a6

label id

f0963394-1070-4d0d-977b-280e888b626b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7

source defined aliases

source span

end: 590
end exclusive: true
exact text: • Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis ( 1.4 , 5.3 )
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 423

source url

https://api.fda.gov/drug/label.json?search=id%3A%22f0963394-1070-4d0d-977b-280e888b626b%22

spl effective date

2024-04-15

spl set id

89cd4f46-b88a-4c10-b25c-47352280dc4e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 7 · positive indication candidate

application numbers

NDA017808

brand names

Miacalcin

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1085
end exclusive: true
exact text: ted ( 1.3 ) Limitations of Use: • Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis ( 1.4 , 5.3 ) 1.1 Treatment of Paget’s Disease of Bone Miacalcin injection is indicated for the treatment of symptomatic Paget’s disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. There is no evidence that the prophylactic use of calcitonin salmon is beneficial in asymptomatic patients. Miacalcin injection should be used only in patients who do not respond to alternative treat
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 391

current approval status

not_reconciled

duplicate text group

dup-a273cf398770bc4ba406

extraction review status

automated_candidate_pending_source_review

generic names

CALCITONIN SALMON

ind-span-6fd637835a637ab2c34e

label id

f0963394-1070-4d0d-977b-280e888b626b

positive predicate support span

end: 664
end exclusive: true
exact text: is indicated
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 652

qualifier mentions

context exact
haracterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion.
kind
biomarker
polarity
not_inferred
span
end
870
end exclusive
true
exact text
alkaline phosphatase and urinary hydroxypro
label id
f0963394-1070-4d0d-977b-280e888b626b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start
827

regulatory links

schema version

0.1.0

source batch sha256

8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7

source defined aliases

source span

end: 885
end exclusive: true
exact text: 1.1 Treatment of Paget’s Disease of Bone Miacalcin injection is indicated for the treatment of symptomatic Paget’s disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion.
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 591

source url

https://api.fda.gov/drug/label.json?search=id%3A%22f0963394-1070-4d0d-977b-280e888b626b%22

spl effective date

2024-04-15

spl set id

89cd4f46-b88a-4c10-b25c-47352280dc4e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 8 · unclassified context

application numbers

NDA017808

brand names

Miacalcin

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1193
end exclusive: true
exact text: symptomatic Paget’s disease of bone in patients with moderate to severe disease characterized by polyostotic involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. There is no evidence that the prophylactic use of calcitonin salmon is beneficial in asymptomatic patients. Miacalcin injection should be used only in patients who do not respond to alternative treatments or for whom such treatments are not suitable (e.g., patients for whom other therapies are contraindica
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 686

current approval status

not_reconciled

duplicate text group

dup-c2c0954268b1c51b460f

extraction review status

automated_candidate_pending_source_review

generic names

CALCITONIN SALMON

ind-span-0ed2fd264539498fa399

label id

f0963394-1070-4d0d-977b-280e888b626b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7

source defined aliases

source span

end: 993
end exclusive: true
exact text: There is no evidence that the prophylactic use of calcitonin salmon is beneficial in asymptomatic patients.
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 886

source url

https://api.fda.gov/drug/label.json?search=id%3A%22f0963394-1070-4d0d-977b-280e888b626b%22

spl effective date

2024-04-15

spl set id

89cd4f46-b88a-4c10-b25c-47352280dc4e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 9 · risk or warning

application numbers

NDA017808

brand names

Miacalcin

classification reasons

risk_or_warning_words_without_positive_predicate

clinical review status

pending

content role

risk_or_warning

context span

end: 1469
end exclusive: true
exact text: involvement with elevated serum alkaline phosphatase and urinary hydroxyproline excretion. There is no evidence that the prophylactic use of calcitonin salmon is beneficial in asymptomatic patients. Miacalcin injection should be used only in patients who do not respond to alternative treatments or for whom such treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). 1.2 Treatment of Hypercalcemia Miacalcin injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is re
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 794

current approval status

not_reconciled

duplicate text group

dup-4d867913323baa770225

extraction review status

automated_candidate_pending_source_review

generic names

CALCITONIN SALMON

ind-span-87d55db3c1b112599625

label id

f0963394-1070-4d0d-977b-280e888b626b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7

source defined aliases

source span

end: 1269
end exclusive: true
exact text: Miacalcin injection should be used only in patients who do not respond to alternative treatments or for whom such treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 994

source url

https://api.fda.gov/drug/label.json?search=id%3A%22f0963394-1070-4d0d-977b-280e888b626b%22

spl effective date

2024-04-15

spl set id

89cd4f46-b88a-4c10-b25c-47352280dc4e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 10 · positive indication candidate

application numbers

NDA017808

brand names

Miacalcin

classification reasons

explicit_positive_indication_predicate
supportive_or_complication_use_words

clinical review status

pending

content role

positive_indication_candidate

context span

end: 1753
end exclusive: true
exact text: ternative treatments or for whom such treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). 1.2 Treatment of Hypercalcemia Miacalcin injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents. 1.3 Treatment of Postmenopausal
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 1070

current approval status

not_reconciled

duplicate text group

dup-f2ac594099b42c612bad

extraction review status

automated_candidate_pending_source_review

generic names

CALCITONIN SALMON

ind-span-0227d4492a49d8ff2229

label id

f0963394-1070-4d0d-977b-280e888b626b

positive predicate support span

end: 1333
end exclusive: true
exact text: is indicated
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 1321

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7

source defined aliases

source span

end: 1553
end exclusive: true
exact text: 1.2 Treatment of Hypercalcemia Miacalcin injection is indicated for the early treatment of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished.
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 1270

source url

https://api.fda.gov/drug/label.json?search=id%3A%22f0963394-1070-4d0d-977b-280e888b626b%22

spl effective date

2024-04-15

spl set id

89cd4f46-b88a-4c10-b25c-47352280dc4e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

supportive_care_candidate

Passage 11 · unclassified context

application numbers

NDA017808

brand names

Miacalcin

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 1920
end exclusive: true
exact text: ent of hypercalcemic emergencies, along with other appropriate agents, when a rapid decrease in serum calcium is required, until more specific treatment of the underlying disease can be accomplished. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents. 1.3 Treatment of Postmenopausal Osteoporosis Miacalcin injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. The evidence of efficacy fo
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 1354

current approval status

not_reconciled

duplicate text group

dup-f9ee36c944626bea5477

extraction review status

automated_candidate_pending_source_review

generic names

CALCITONIN SALMON

ind-span-abfaa9c3afa54ad4f58e

label id

f0963394-1070-4d0d-977b-280e888b626b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7

source defined aliases

source span

end: 1720
end exclusive: true
exact text: It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents.
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 1554

source url

https://api.fda.gov/drug/label.json?search=id%3A%22f0963394-1070-4d0d-977b-280e888b626b%22

spl effective date

2024-04-15

spl set id

89cd4f46-b88a-4c10-b25c-47352280dc4e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 12 · positive indication candidate

application numbers

NDA017808

brand names

Miacalcin

classification reasons

explicit_positive_indication_predicate
no_tumor_directed_keyword_in_positive_statement

clinical review status

pending

content role

positive_indication_candidate

context span

end: 2092
end exclusive: true
exact text: ing disease can be accomplished. It may also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents. 1.3 Treatment of Postmenopausal Osteoporosis Miacalcin injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. The evidence of efficacy for calcitonin salmon injection is based on increases in total body calcium observed in clinical trials. Fracture reduction efficacy has not been demonstrated. Miacalcin inje
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 1521

current approval status

not_reconciled

duplicate text group

dup-bc41aa560bcd98a892d9

extraction review status

automated_candidate_pending_source_review

generic names

CALCITONIN SALMON

ind-span-f31e6b447caec6dfebe4

label id

f0963394-1070-4d0d-977b-280e888b626b

positive predicate support span

end: 1798
end exclusive: true
exact text: is indicated
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 1786

qualifier mentions

context exact
atment of postmenopausal osteoporosis in women greater than 5 years postmenopause.
kind
age
polarity
not_inferred
span
end
1877
end exclusive
true
exact text
5 years
label id
f0963394-1070-4d0d-977b-280e888b626b
offset unit
unicode_code_points
source array index
0
source field
indications_and_usage_exact
source text sha256
d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start
1870

regulatory links

schema version

0.1.0

source batch sha256

8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7

source defined aliases

source span

end: 1892
end exclusive: true
exact text: 1.3 Treatment of Postmenopausal Osteoporosis Miacalcin injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause.
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 1721

source url

https://api.fda.gov/drug/label.json?search=id%3A%22f0963394-1070-4d0d-977b-280e888b626b%22

spl effective date

2024-04-15

spl set id

89cd4f46-b88a-4c10-b25c-47352280dc4e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

non_oncology_or_unclear_candidate

Passage 13 · unclassified context

application numbers

NDA017808

brand names

Miacalcin

classification reasons

no_unambiguous_positive_indication_predicate

clinical review status

pending

content role

unclassified_context

context span

end: 2222
end exclusive: true
exact text: osteroids, or other agents. 1.3 Treatment of Postmenopausal Osteoporosis Miacalcin injection is indicated for the treatment of postmenopausal osteoporosis in women greater than 5 years postmenopause. The evidence of efficacy for calcitonin salmon injection is based on increases in total body calcium observed in clinical trials. Fracture reduction efficacy has not been demonstrated. Miacalcin injection should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies ar
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 1693

current approval status

not_reconciled

duplicate text group

dup-37056daa0be43e8b930e

extraction review status

automated_candidate_pending_source_review

generic names

CALCITONIN SALMON

ind-span-8ca9680891a3ab901ec1

label id

f0963394-1070-4d0d-977b-280e888b626b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7

source defined aliases

source span

end: 2022
end exclusive: true
exact text: The evidence of efficacy for calcitonin salmon injection is based on increases in total body calcium observed in clinical trials.
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 1893

source url

https://api.fda.gov/drug/label.json?search=id%3A%22f0963394-1070-4d0d-977b-280e888b626b%22

spl effective date

2024-04-15

spl set id

89cd4f46-b88a-4c10-b25c-47352280dc4e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

unclear

Passage 14 · limitation of use

application numbers

NDA017808

brand names

Miacalcin

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 2277
end exclusive: true
exact text: tmenopausal osteoporosis in women greater than 5 years postmenopause. The evidence of efficacy for calcitonin salmon injection is based on increases in total body calcium observed in clinical trials. Fracture reduction efficacy has not been demonstrated. Miacalcin injection should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 1823

current approval status

not_reconciled

duplicate text group

dup-98ffb36fb5b66757772a

extraction review status

automated_candidate_pending_source_review

generic names

CALCITONIN SALMON

ind-span-8d158a8a8cbddd0fc208

label id

f0963394-1070-4d0d-977b-280e888b626b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7

source defined aliases

source span

end: 2077
end exclusive: true
exact text: Fracture reduction efficacy has not been demonstrated.
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 2023

source url

https://api.fda.gov/drug/label.json?search=id%3A%22f0963394-1070-4d0d-977b-280e888b626b%22

spl effective date

2024-04-15

spl set id

89cd4f46-b88a-4c10-b25c-47352280dc4e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 15 · risk or warning

application numbers

NDA017808

brand names

Miacalcin

classification reasons

risk_or_warning_words_without_positive_predicate

clinical review status

pending

content role

risk_or_warning

context span

end: 2512
end exclusive: true
exact text: postmenopause. The evidence of efficacy for calcitonin salmon injection is based on increases in total body calcium observed in clinical trials. Fracture reduction efficacy has not been demonstrated. Miacalcin injection should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). 1.4 Important Limitations of Use Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis [see Warnings
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 1878

current approval status

not_reconciled

duplicate text group

dup-5f6fd9686a57ab513ce0

extraction review status

automated_candidate_pending_source_review

generic names

CALCITONIN SALMON

ind-span-62936dde2da3c581e730

label id

f0963394-1070-4d0d-977b-280e888b626b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7

source defined aliases

source span

end: 2312
end exclusive: true
exact text: Miacalcin injection should be reserved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies).
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 2078

source url

https://api.fda.gov/drug/label.json?search=id%3A%22f0963394-1070-4d0d-977b-280e888b626b%22

spl effective date

2024-04-15

spl set id

89cd4f46-b88a-4c10-b25c-47352280dc4e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 16 · risk or warning

application numbers

NDA017808

brand names

Miacalcin

classification reasons

risk_or_warning_words_without_positive_predicate

clinical review status

pending

content role

risk_or_warning

context span

end: 2537
end exclusive: true
exact text: ved for patients for whom alternative treatments are not suitable (e.g., patients for whom other therapies are contraindicated or for patients who are intolerant or unwilling to use other therapies). 1.4 Important Limitations of Use Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis [see Warnings and Precautions (5.3) ] .
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 2113

current approval status

not_reconciled

duplicate text group

dup-08b224b5a72cda937e90

extraction review status

automated_candidate_pending_source_review

generic names

CALCITONIN SALMON

ind-span-b71d65d969920e07c709

label id

f0963394-1070-4d0d-977b-280e888b626b

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

8c4843bd18fc22d01ea4a91909737f3bbfdde09c17c5b243ce13d05c406cc6c7

source defined aliases

source span

end: 2537
end exclusive: true
exact text: 1.4 Important Limitations of Use Due to the possible association between malignancy and calcitonin salmon use, the need for continued therapy should be re-evaluated on a periodic basis [see Warnings and Precautions (5.3) ] .
label id: f0963394-1070-4d0d-977b-280e888b626b
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: d980f007d694b8de37c322379b71add0b4b0b6363ca75a289e1c1a32db874692
start: 2313

source url

https://api.fda.gov/drug/label.json?search=id%3A%22f0963394-1070-4d0d-977b-280e888b626b%22

spl effective date

2024-04-15

spl set id

89cd4f46-b88a-4c10-b25c-47352280dc4e

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Preserved source evidence · Not medical advice