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LABELS · 1ed05dab-581e-42da-aafc-26c3a759e9ac

Natesto nasal gel

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
2025-07-22
Captured
2026-09-09T23:37:42.544548+00:00
Current indication reconciliation
Not reconciled

Indications and usage: exact source text

  1. 1. INDICATIONS AND USAGE Natesto is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Limitations of use: Safety and efficacy of Natesto in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established. Safety and efficacy of Natesto in males less than 18 years old have not been established [see Use in Specific Populations ( 8.4 )] . Natesto is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) ( 1 ) Hypogonadotropic hypogonadism (congenital or acquired) ( 1 ) Limitations of use: Safety and efficacy of Natesto in men with "age-related hypogonadism" have not been established ( 1 ). Safety and efficacy of Natesto in males less than 18 years old have not been established. ( 1 , 8.4 )
Full extracted label fields
application numbers
  1. NDA205488
boxed warning exact
    brand names
    1. Natesto nasal gel
    current indication status
    not_reconciled
    dailymed set url
    https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dea6bed1-eaca-11e3-ac10-0800200c9a66
    generic names
    1. TESTOSTERONE
    id
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    indications and usage exact
    1. 1. INDICATIONS AND USAGE Natesto is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Limitations of use: Safety and efficacy of Natesto in men with "age-related hypogonadism" (also referred to as "late-onset hypogonadism") have not been established. Safety and efficacy of Natesto in males less than 18 years old have not been established [see Use in Specific Populations ( 8.4 )] . Natesto is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) ( 1 ) Hypogonadotropic hypogonadism (congenital or acquired) ( 1 ) Limitations of use: Safety and efficacy of Natesto in men with "age-related hypogonadism" have not been established ( 1 ). Safety and efficacy of Natesto in males less than 18 years old have not been established. ( 1 , 8.4 )
    indications and usage tables exact
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      recent major changes exact
      1. Warnings and Precautions, Venous Thromboembolism ( 5.4 ) 07/2025 Warnings and Precautions, Blood Pressure Increases ( 5.6 ) 07/2025 Warnings and Precautions, Cardiovascular Risk (5.6) Removed 07/2025
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        products
        1. Active Ingredient
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          Appl No
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          Drug Name
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          Form
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          Product No
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          Reference Drug
          1
          Reference Standard
          1
          Strength
          5.5MG/0.122GM ACTUATION
          marketing status
          1. Prescription

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            1. INDICATIONS AND USAGE Natesto is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome
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              S AND USAGE Natesto is indicated for replacement therapy in adult males for conditions associated with a deficiency or absenc
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                INDICATIONS AND USAGE Natesto is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
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                1. INDICATIONS AND USAGE Natesto is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (co
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                    Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.
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                    lure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. The
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                                                          1ed05dab-581e-42da-aafc-26c3a759e9ac
                                                          positive predicate support span
                                                          Source null
                                                          qualifier mentions
                                                            regulatory links
                                                              schema version
                                                              0.1.0
                                                              source batch sha256
                                                              fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
                                                              source defined aliases
                                                                source span
                                                                end
                                                                1679
                                                                end exclusive
                                                                true
                                                                exact text
                                                                ( 1 , 8.4 )
                                                                label id
                                                                1ed05dab-581e-42da-aafc-26c3a759e9ac
                                                                offset unit
                                                                unicode_code_points
                                                                source array index
                                                                0
                                                                source field
                                                                indications_and_usage_exact
                                                                source text sha256
                                                                23e9728cf8acbe8f8ac922ec0533f54faa18f2027d04c43be8ca77f61e175d0f
                                                                start
                                                                1668
                                                                source url
                                                                https://api.fda.gov/drug/label.json?search=id%3A%221ed05dab-581e-42da-aafc-26c3a759e9ac%22
                                                                spl effective date
                                                                2025-07-22
                                                                spl set id
                                                                dea6bed1-eaca-11e3-ac10-0800200c9a66
                                                                spl version
                                                                20
                                                                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

                                                                Preserved source evidence · Not medical advice