TriangleLABELS · b8a1cc48-9aaf-486a-9305-090acccb5c02
PROMACTA
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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
- 2025-12-18
- Captured
- 2026-09-09T23:37:58.719708+00:00
- Current indication reconciliation
- Not reconciled
Boxed warning in this label
- WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of hepatic decompensation [see Warnings and Precautions (5.1)] . PROMACTA may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended [see Warnings and Precautions (5.2)] . WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY See full prescribing information for complete boxed warning. In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of hepatic decompensation. ( 5.1 ) PROMACTA may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended. ( 5.2 )
Indications and usage: exact source text
- 1 INDICATIONS AND USAGE PROMACTA is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. ( 1.1 ) for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. ( 1.2 ) in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. ( 1.3 ) for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. ( 1.3 ) Limitations of Use: PROMACTA is not indicated for the treatment of patients with myelodysplastic syndrome (MDS). ( 1.4 ) Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. ( 1.4 ) 1.1 Treatment of Thrombocytopenia in Patients With Persistent or Chronic Immune Thrombocytopenia PROMACTA is indicated for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. 1.2 Treatment of Thrombocytopenia in Patients With Hepatitis C Infection PROMACTA is indicated for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. 1.3 Treatment of Severe Aplastic Anemia PROMACTA is indicated in combination with standard immunosuppressive therapy (IST) for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. PROMACTA is indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. 1.4 Limitations of Use PROMACTA is not indicated for the treatment of patients with myelodysplastic syndromes (MDS) [see Warnings and Precautions (5.3)] . Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.
Full extracted label fields
- application numbers
- NDA022291
- NDA207027
- boxed warning exact
- WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of hepatic decompensation [see Warnings and Precautions (5.1)] . PROMACTA may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended [see Warnings and Precautions (5.2)] . WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY See full prescribing information for complete boxed warning. In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of hepatic decompensation. ( 5.1 ) PROMACTA may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended. ( 5.2 )
- brand names
- PROMACTA
- current indication status
- not_reconciled
- dailymed set url
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7714a0ed-34bb-46e6-a0a5-b363908b22c2
- generic names
- ELTROMBOPAG OLAMINE
- id
- b8a1cc48-9aaf-486a-9305-090acccb5c02
- indications and usage exact
- 1 INDICATIONS AND USAGE PROMACTA is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. ( 1.1 ) for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. ( 1.2 ) in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. ( 1.3 ) for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. ( 1.3 ) Limitations of Use: PROMACTA is not indicated for the treatment of patients with myelodysplastic syndrome (MDS). ( 1.4 ) Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. ( 1.4 ) 1.1 Treatment of Thrombocytopenia in Patients With Persistent or Chronic Immune Thrombocytopenia PROMACTA is indicated for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. 1.2 Treatment of Thrombocytopenia in Patients With Hepatitis C Infection PROMACTA is indicated for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. 1.3 Treatment of Severe Aplastic Anemia PROMACTA is indicated in combination with standard immunosuppressive therapy (IST) for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. PROMACTA is indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. 1.4 Limitations of Use PROMACTA is not indicated for the treatment of patients with myelodysplastic syndromes (MDS) [see Warnings and Precautions (5.3)] . Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.
- indications and usage tables exact
- is original packager
- true
- manufacturer names
- Novartis Pharmaceuticals Corporation
- matched search terms
- myelodysplastic
- package ndcs
- 0078-0684-15
- 0078-0685-15
- 0078-0686-15
- 0078-0686-55
- 0078-0687-15
- 0078-0972-19
- 0078-0972-23
- 0078-0972-61
- 0078-0697-19
- 0078-0697-23
- 0078-0697-61
- product ndcs
- 0078-0684
- 0078-0685
- 0078-0686
- 0078-0687
- 0078-0972
- 0078-0697
- product types
- HUMAN PRESCRIPTION DRUG
- recent major changes exact
- Warnings and Precautions, Laboratory Test Interference ( 5.6 ) 6/2025
- record type
- complete_spl_indications_section_candidate
- routes
- ORAL
- rxcuis
- 825421
- 825425
- 825427
- 825429
- 884617
- 884619
- 1245001
- 1245003
- 1859498
- 1859501
- 2058980
- 2058981
- source batch
- file
- /private/tmp/cancer-full-research/indications/raw/labels-00600.json
- meta
- disclaimer
- Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
- last updated
- 2026-09-09
- results
- limit
- 100
- skip
- 600
- total
- 830
- sha256
- a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
- source url
- https://api.fda.gov/drug/label.json?search=id%3A%22b8a1cc48-9aaf-486a-9305-090acccb5c02%22
- spl effective date
- 2025-12-18
- spl effective time
- 20251218
- spl set id
- 7714a0ed-34bb-46e6-a0a5-b363908b22c2
- spl version
- 31
- substance names
- ELTROMBOPAG OLAMINE
- uniis
- 4U07F515LG
- verification flags
- oncology_keyword_candidate_not_clinically_classified
- spl_text_not_verified_identical_to_latest_approved_label
- individual_indications_not_split_or_reconciled
Drugs@FDA application source records
- application number
- NDA022291
- payload
- all indexed label documents
- Appl No
- 022291
- Application Docs Date
- 2011-12-06 00:00:00
- Application Docs ID
- 17206
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s006lbl.pdf
- Submission No
- 6
- Submission Type
- SUPPL
- Appl No
- 022291
- Application Docs Date
- 2014-02-11 00:00:00
- Application Docs ID
- 17207
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291s010lbl.pdf
- Submission No
- 10
- Submission Type
- SUPPL
- Appl No
- 022291
- Application Docs Date
- 2014-04-28 00:00:00
- Application Docs ID
- 17208
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291Orig1s011lbl.pdf
- Submission No
- 11
- Submission Type
- SUPPL
- Appl No
- 022291
- Application Docs Date
- 2015-06-12 00:00:00
- Application Docs ID
- 17209
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022291s015lbl.pdf
- Submission No
- 15
- Submission Type
- SUPPL
- Appl No
- 022291
- Application Docs Date
- 2008-11-21 00:00:00
- Application Docs ID
- 38519
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022291lbl.pdf
- Submission No
- 1
- Submission Type
- ORIG
- Appl No
- 022291
- Application Docs Date
- 2011-03-04 00:00:00
- Application Docs ID
- 38520
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022291s001lbl.pdf
- Submission No
- 1
- Submission Type
- SUPPL
- Appl No
- 022291
- Application Docs Date
- 2012-11-19 00:00:00
- Application Docs ID
- 38521
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022291s008lbl.pdf
- Submission No
- 8
- Submission Type
- SUPPL
- Appl No
- 022291
- Application Docs Date
- 2014-08-27 00:00:00
- Application Docs ID
- 38522
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022291s012lbl.pdf
- Submission No
- 12
- Submission Type
- SUPPL
- Appl No
- 022291
- Application Docs Date
- 2015-04-10 00:00:00
- Application Docs ID
- 38523
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022291s014lbl.pdf
- Submission No
- 14
- Submission Type
- SUPPL
- Appl No
- 022291
- Application Docs Date
- 2016-10-17 00:00:00
- Application Docs ID
- 45615
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022291s016,207027s001lbl.pdf
- Submission No
- 16
- Submission Type
- SUPPL
- Appl No
- 022291
- Application Docs Date
- 2017-03-10 00:00:00
- Application Docs ID
- 47518
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022291s017lbl.pdf
- Submission No
- 17
- Submission Type
- SUPPL
- Appl No
- 022291
- Application Docs Date
- 2017-07-10 00:00:00
- Application Docs ID
- 48932
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022291s018lbl.pdf
- Submission No
- 18
- Submission Type
- SUPPL
- all submission records
- Appl No
- 022291
- Review Priority
- N/A
- Submission Class Code ID
- 4
- Submission No
- 40
- Submission Status
- AP
- Submission Status Date
- 2024-12-27 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022291
- Review Priority
- N/A
- Submission Class Code ID
- 4
- Submission No
- 38
- Submission Status
- AP
- Submission Status Date
- 2023-07-06 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022291
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 37
- Submission Status
- AP
- Submission Status Date
- 2023-03-09 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022291
- Review Priority
- N/A
- Submission Class Code ID
- 4
- Submission No
- 35
- Submission Status
- AP
- Submission Status Date
- 2022-11-15 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022291
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 33
- Submission Status
- AP
- Submission Status Date
- 2022-03-31 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022291
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 31
- Submission Status
- AP
- Submission Status Date
- 2021-02-03 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022291
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 27
- Submission Status
- AP
- Submission Status Date
- 2020-04-29 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022291
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 26
- Submission Status
- AP
- Submission Status Date
- 2020-04-28 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022291
- Review Priority
- PRIORITY
- Submission Class Code ID
- 2
- Submission No
- 21
- Submission Status
- AP
- Submission Status Date
- 2018-11-16 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022291
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 20
- Submission Status
- AP
- Submission Status Date
- 2018-07-24 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022291
- Review Priority
- 901 REQUIRED
- Submission Class Code ID
- 3
- Submission No
- 19
- Submission Status
- AP
- Submission Status Date
- 2017-10-04 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022291
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 18
- Submission Status
- AP
- Submission Status Date
- 2017-07-05 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- application number
- NDA022291
- approval interpretation
- Application linkage and approved submission are not indication-level current approval verification
- current indication status
- not_reconciled
- drugsfda url
- https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022291
- has approved submission record
- true
- latest approved submission date
- 2025-06-06
- latest label selection rule
- max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
- latest posted label documents
- Appl No
- 022291
- Application Docs Date
- 2025-08-29 00:00:00
- Application Docs ID
- 83224
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022291Orig1s040lbl.pdf
- Submission No
- 40
- Submission Type
- SUPPL
- official application record
- Appl No
- 022291
- Appl Public Notes
- Appl Type
- NDA
- Sponsor Name
- NOVARTIS
- openfda application present
- true
- products
- Active Ingredient
- ELTROMBOPAG OLAMINE
- Appl No
- 022291
- Drug Name
- PROMACTA
- Form
- TABLET;ORAL
- Product No
- 001
- Reference Drug
- 1
- Reference Standard
- 0
- Strength
- EQ 25MG ACID
- marketing status
- Prescription
- Active Ingredient
- ELTROMBOPAG OLAMINE
- Appl No
- 022291
- Drug Name
- PROMACTA
- Form
- TABLET;ORAL
- Product No
- 002
- Reference Drug
- 1
- Reference Standard
- 0
- Strength
- EQ 50MG ACID
- marketing status
- Prescription
- Active Ingredient
- ELTROMBOPAG OLAMINE
- Appl No
- 022291
- Drug Name
- PROMACTA
- Form
- TABLET;ORAL
- Product No
- 003
- Reference Drug
- 1
- Reference Standard
- 1
- Strength
- EQ 75MG ACID
- marketing status
- Prescription
- Active Ingredient
- ELTROMBOPAG OLAMINE
- Appl No
- 022291
- Drug Name
- PROMACTA
- Form
- TABLET;ORAL
- Product No
- 004
- Reference Drug
- 1
- Reference Standard
- 0
- Strength
- EQ 12.5MG ACID
- marketing status
- Prescription
- Active Ingredient
- ELTROMBOPAG OLAMINE
- Appl No
- 022291
- Drug Name
- PROMACTA
- Form
- TABLET;ORAL
- Product No
- 005
- Reference Drug
- 1
- Reference Standard
- 0
- Strength
- EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
- marketing status
- Discontinued
- application number
- NDA207027
- payload
- all indexed label documents
- Appl No
- 207027
- Application Docs Date
- 2015-08-25 00:00:00
- Application Docs ID
- 40578
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207027s000lbl.pdf
- Submission No
- 1
- Submission Type
- ORIG
- Appl No
- 207027
- Application Docs Date
- 2016-10-17 00:00:00
- Application Docs ID
- 45616
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022291s016,207027s001lbl.pdf
- Submission No
- 1
- Submission Type
- SUPPL
- Appl No
- 207027
- Application Docs Date
- 2017-03-10 00:00:00
- Application Docs ID
- 47522
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207027s002lbl.pdf
- Submission No
- 2
- Submission Type
- SUPPL
- Appl No
- 207027
- Application Docs Date
- 2017-07-10 00:00:00
- Application Docs ID
- 48931
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207027s003lbl.pdf
- Submission No
- 3
- Submission Type
- SUPPL
- Appl No
- 207027
- Application Docs Date
- 2018-05-31 00:00:00
- Application Docs ID
- 54388
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207027s004lbl.pdf
- Submission No
- 4
- Submission Type
- SUPPL
- Appl No
- 207027
- Application Docs Date
- 2018-07-25 00:00:00
- Application Docs ID
- 54969
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022291s020,207027s005lbl.pdf
- Submission No
- 5
- Submission Type
- SUPPL
- Appl No
- 207027
- Application Docs Date
- 2018-10-04 00:00:00
- Application Docs ID
- 55814
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207027s006lbl.pdf
- Submission No
- 6
- Submission Type
- SUPPL
- Appl No
- 207027
- Application Docs Date
- 2019-04-25 00:00:00
- Application Docs ID
- 58421
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207027s008lbl.pdf
- Submission No
- 8
- Submission Type
- SUPPL
- Appl No
- 207027
- Application Docs Date
- 2020-05-01 00:00:00
- Application Docs ID
- 62797
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022291s027,207027s010lbl.pdf
- Submission No
- 10
- Submission Type
- SUPPL
- Appl No
- 207027
- Application Docs Date
- 2021-02-04 00:00:00
- Application Docs ID
- 66087
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207027Orig1s013lbl.pdf
- Submission No
- 13
- Submission Type
- SUPPL
- Appl No
- 207027
- Application Docs Date
- 2021-02-04 00:00:00
- Application Docs ID
- 66089
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207027s014lbl.pdf
- Submission No
- 14
- Submission Type
- SUPPL
- Appl No
- 207027
- Application Docs Date
- 2022-04-05 00:00:00
- Application Docs ID
- 70692
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022291s033,207027s015lbl.pdf
- Submission No
- 15
- Submission Type
- SUPPL
- all submission records
- Appl No
- 207027
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 20
- Submission Status
- AP
- Submission Status Date
- 2025-06-06 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 207027
- Review Priority
- STANDARD
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Passage 8 · unclassified context
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Passage 9 · unclassified context
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Passage 10 · limitation of use
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Passage 11 · limitation of use
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Passage 12 · unclassified context
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Passage 13 · positive indication candidate
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- https://api.fda.gov/drug/label.json?search=id%3A%22b8a1cc48-9aaf-486a-9305-090acccb5c02%22
- spl effective date
- 2025-12-18
- spl set id
- 7714a0ed-34bb-46e6-a0a5-b363908b22c2
- spl version
- 31
- 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 19 · limitation of use
- application numbers
- NDA022291
- NDA207027
- brand names
- PROMACTA
- classification reasons
- negative_or_not_established_clause
- clinical review status
- pending
- content role
- limitation_of_use
- context span
- end
- 3072
- end exclusive
- true
- exact text
- ents 2 years and older with severe aplastic anemia. PROMACTA is indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. 1.4 Limitations of Use PROMACTA is not indicated for the treatment of patients with myelodysplastic syndromes (MDS) [see Warnings and Precautions (5.3)] . Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.
- label id
- b8a1cc48-9aaf-486a-9305-090acccb5c02
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- 8e4b4aad148cc3973ebbe7d822c1979ab8b8e8e59c3b4d4743c5c97cdcd72583
- start
- 2549
- current approval status
- not_reconciled
- duplicate text group
- dup-389f70744081841ef5ea
- extraction review status
- automated_candidate_pending_source_review
- generic names
- ELTROMBOPAG OLAMINE
- id
- ind-span-7598bb100a5b0b0038b1
- label id
- b8a1cc48-9aaf-486a-9305-090acccb5c02
- positive predicate support span
- Source null
- qualifier mentions
- regulatory links
- schema version
- 0.1.0
- source batch sha256
- a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
- source defined aliases
- source span
- end
- 2903
- end exclusive
- true
- exact text
- 1.4 Limitations of Use PROMACTA is not indicated for the treatment of patients with myelodysplastic syndromes (MDS) [see Warnings and Precautions (5.3)] .
- label id
- b8a1cc48-9aaf-486a-9305-090acccb5c02
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- 8e4b4aad148cc3973ebbe7d822c1979ab8b8e8e59c3b4d4743c5c97cdcd72583
- start
- 2749
- source url
- https://api.fda.gov/drug/label.json?search=id%3A%22b8a1cc48-9aaf-486a-9305-090acccb5c02%22
- spl effective date
- 2025-12-18
- spl set id
- 7714a0ed-34bb-46e6-a0a5-b363908b22c2
- spl version
- 31
- 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 20 · limitation of use
- application numbers
- NDA022291
- NDA207027
- brand names
- PROMACTA
- classification reasons
- negative_or_not_established_clause
- clinical review status
- pending
- content role
- limitation_of_use
- context span
- end
- 3072
- end exclusive
- true
- exact text
- cient response to immunosuppressive therapy. 1.4 Limitations of Use PROMACTA is not indicated for the treatment of patients with myelodysplastic syndromes (MDS) [see Warnings and Precautions (5.3)] . Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.
- label id
- b8a1cc48-9aaf-486a-9305-090acccb5c02
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- 8e4b4aad148cc3973ebbe7d822c1979ab8b8e8e59c3b4d4743c5c97cdcd72583
- start
- 2704
- current approval status
- not_reconciled
- duplicate text group
- dup-dbaa19dcad4c593dee35
- extraction review status
- automated_candidate_pending_source_review
- generic names
- ELTROMBOPAG OLAMINE
- id
- ind-span-1761dcae6a9dbc54b532
- label id
- b8a1cc48-9aaf-486a-9305-090acccb5c02
- positive predicate support span
- Source null
- qualifier mentions
- context exact
- Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.
- kind
- regimen
- polarity
- not_inferred
- span
- end
- 3071
- end exclusive
- true
- exact text
- in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection
- label id
- b8a1cc48-9aaf-486a-9305-090acccb5c02
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- 8e4b4aad148cc3973ebbe7d822c1979ab8b8e8e59c3b4d4743c5c97cdcd72583
- start
- 2950
- regulatory links
- schema version
- 0.1.0
- source batch sha256
- a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
- source defined aliases
- source span
- end
- 3072
- end exclusive
- true
- exact text
- Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.
- label id
- b8a1cc48-9aaf-486a-9305-090acccb5c02
- offset unit
- unicode_code_points
- source array index
- 0
- source field
- indications_and_usage_exact
- source text sha256
- 8e4b4aad148cc3973ebbe7d822c1979ab8b8e8e59c3b4d4743c5c97cdcd72583
- start
- 2904
- source url
- https://api.fda.gov/drug/label.json?search=id%3A%22b8a1cc48-9aaf-486a-9305-090acccb5c02%22
- spl effective date
- 2025-12-18
- spl set id
- 7714a0ed-34bb-46e6-a0a5-b363908b22c2
- spl version
- 31
- 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