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LABELS · 58569bae-90e9-492c-a026-9a7b8797b3b4

Delestrogen

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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
2026-05-13
Captured
2026-09-09T23:37:47.659725+00:00
Current indication reconciliation
Not reconciled
Boxed warning in this label
  1. ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of “natural” estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses [see WARNINGS , Malignant neoplasms , Endometrial cancer ]. CARDIOVASCULAR AND OTHER RISKS Estrogens and progestins should not be used for the prevention of cardiovascular disease [see WARNINGS , Cardiovascular disorders ]. The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo [see CLINICAL PHARMACOLOGY , Clinical Studies ]. The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy [see CLINICAL PHARMACOLOGY , Clinical Studies ]. Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
  2. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT DELESTROGEN (AN ESTROGEN HORMONE)? Estrogens increase the chances of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia. You and your healthcare provider should talk regularly about whether you still need treatment with DELESTROGEN.

Indications and usage: exact source text

  1. INDICATIONS AND USAGE DELESTROGEN (estradiol valerate injection, USP) is indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
Full extracted label fields
application numbers
  1. NDA009402
boxed warning exact
  1. ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of “natural” estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses [see WARNINGS , Malignant neoplasms , Endometrial cancer ]. CARDIOVASCULAR AND OTHER RISKS Estrogens and progestins should not be used for the prevention of cardiovascular disease [see WARNINGS , Cardiovascular disorders ]. The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo [see CLINICAL PHARMACOLOGY , Clinical Studies ]. The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy [see CLINICAL PHARMACOLOGY , Clinical Studies ]. Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
  2. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT DELESTROGEN (AN ESTROGEN HORMONE)? Estrogens increase the chances of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia. You and your healthcare provider should talk regularly about whether you still need treatment with DELESTROGEN.
brand names
  1. Delestrogen
current indication status
not_reconciled
dailymed set url
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e8f94df9-0692-4462-a7f0-fe019a0a3f07
generic names
  1. ESTRADIOL VALERATE
id
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indications and usage exact
  1. INDICATIONS AND USAGE DELESTROGEN (estradiol valerate injection, USP) is indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. 4. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
indications and usage tables exact
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    manufacturer names
    1. Par Health USA, LLC
    matched search terms
    1. carcinoma
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    1. 42023-110-01
    2. 42023-111-01
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    2. 42023-111
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    1. HUMAN PRESCRIPTION DRUG
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      substance names
      1. ESTRADIOL VALERATE
      uniis
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      1. application number
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        payload
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        1. Appl No
          009402
          Application Docs Date
          2004-06-02 00:00:00
          Application Docs ID
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          Application Docs Type ID
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          Submission No
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        2. Appl No
          009402
          Application Docs Date
          2003-12-16 00:00:00
          Application Docs ID
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          Application Docs Title
          0
          Application Docs Type ID
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          Submission No
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          Submission Type
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        3. Appl No
          009402
          Application Docs Date
          2004-07-28 00:00:00
          Application Docs ID
          33002
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          40
          Submission Type
          SUPPL
        4. Appl No
          009402
          Application Docs Date
          2017-11-02 00:00:00
          Application Docs ID
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          Application Docs Type ID
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          Submission No
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        5. Appl No
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          Application Docs Date
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          Application Docs ID
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          Submission No
          60
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        6. Appl No
          009402
          Application Docs Date
          2024-02-20 00:00:00
          Application Docs ID
          77565
          Application Docs Title
          0
          Application Docs Type ID
          2
          Submission No
          63
          Submission Type
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        1. Appl No
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          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          63
          Submission Status
          AP
          Submission Status Date
          2024-02-15 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        2. Appl No
          009402
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          60
          Submission Status
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          Submission Status Date
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        3. Appl No
          009402
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          52
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          Submission Status Date
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        4. Appl No
          009402
          Review Priority
          Submission Class Code ID
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          Submission No
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          Submission Status
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          Submission Status Date
          2016-03-10 00:00:00
          Submission Type
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          Submissions Public Notes
        5. Appl No
          009402
          Review Priority
          Submission Class Code ID
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          Submission No
          47
          Submission Status
          AP
          Submission Status Date
          2015-10-20 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        6. Appl No
          009402
          Review Priority
          Submission Class Code ID
          4
          Submission No
          46
          Submission Status
          AP
          Submission Status Date
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          Submission Type
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          Submissions Public Notes
        7. Appl No
          009402
          Review Priority
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          Submission No
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          Submission Type
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          Submissions Public Notes
        8. Appl No
          009402
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          40
          Submission Status
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          Submission Status Date
          2004-07-26 00:00:00
          Submission Type
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          Submissions Public Notes
        9. Appl No
          009402
          Review Priority
          STANDARD
          Submission Class Code ID
          3
          Submission No
          39
          Submission Status
          AP
          Submission Status Date
          2003-12-12 00:00:00
          Submission Type
          SUPPL
          Submissions Public Notes
        10. Appl No
          009402
          Review Priority
          Submission Class Code ID
          4
          Submission No
          38
          Submission Status
          AP
          Submission Status Date
          2002-07-17 00:00:00
          Submission Type
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          Submissions Public Notes
        11. Appl No
          009402
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
          37
          Submission Status
          AP
          Submission Status Date
          2003-12-12 00:00:00
          Submission Type
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          Submissions Public Notes
        12. Appl No
          009402
          Review Priority
          STANDARD
          Submission Class Code ID
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          Submission No
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          Submission Status Date
          1998-06-17 00:00:00
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          Submissions Public Notes
        application number
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        approval interpretation
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        current indication status
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        latest approved submission date
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        latest posted label documents
        1. Appl No
          009402
          Application Docs Date
          2024-02-20 00:00:00
          Application Docs ID
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          Application Docs Title
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          Submission No
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        Appl Public Notes
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        products
        1. Active Ingredient
          ESTRADIOL VALERATE
          Appl No
          009402
          Drug Name
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          Form
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          Product No
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          Reference Drug
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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
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          Reference Standard
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          40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
          marketing status
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        3. Active Ingredient
          ESTRADIOL VALERATE
          Appl No
          009402
          Drug Name
          DELESTROGEN
          Form
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          Product No
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          Reference Drug
          1
          Reference Standard
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          Strength
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          marketing status
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      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
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      INDICATIONS AND USAGE DELESTROGEN (estradiol valerate injection, USP) is indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescri
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            INDICATIONS AND USAGE DELESTROGEN (estradiol valerate injection, USP) is indicated in the: 1.
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            INDICATIONS AND USAGE DELESTROGEN (estradiol valerate injection, USP) is indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vagi
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                  Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2.
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                  INDICATIONS AND USAGE DELESTROGEN (estradiol valerate injection, USP) is indicated in the: 1. Treatment of moderate to severe vasomotor symptoms associated with the menopause. 2. Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. 3. Treatment of hypoestrogenism due to hypogonadism, castration or
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                        Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause.
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                                        Preserved source evidence · Not medical advice