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FDA NDA · NDA214846

MYFEMBREE

relugolix, estradiol hemihydrate, and norethindrone acetate

Sponsor: SUMITOMO PHARMA AM

APPLICATION
NDA214846
TYPE
NDA
ORIGINAL APPROVAL
2021-05-26
LATEST ACTION
2025-08-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MYFEMBREE · ReferencePrescription
ESTRADIOL 1MG, NORETHINDRONE ACETATE 0.5MG, RELUGOLIX 40MG · TABLET · ORAL

Approval history

2025-08-27Labeling · Supplement 12 · standard — Label ↗AP
2024-07-17Labeling · Supplement 8 · standard — Letter ↗AP
2024-04-30Efficacy · Supplement 7 · standard — Label ↗AP
2023-01-27Efficacy · Supplement 5 · standard — Label ↗AP
2023-01-27Labeling · Supplement 6 · standard — Label ↗AP
2022-08-05Efficacy · Supplement 2 · standard — Letter ↗AP
2021-05-26Type 4 - New Combination · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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