FDA Ends Review of Certain Estrogen-Androgen Combination Drugs
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
The FDA says certain estrogen-androgen fixed-combination drug products, including Syntest D.S. and Syntest H.S. tablets and similar products, have not been shown to work for the uses listed on their labels. All pending hearing requests in the long-running review have been withdrawn, so the agency is closing the proceeding with a final finding on effectiveness. Starting June 26, 2026, companies may not ship these products in interstate commerce unless the product has an approved new drug application or abbreviated new drug application. Drug manufacturers, distributors, pharmacies, and compliance teams should check whether any affected products remain in their supply chains and confirm FDA approval status before sale or shipment.
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Key Changes
- FDA finds that the covered estrogen-androgen combination drug products have not been shown to be effective for their labeled uses.
- All outstanding hearing requests in the DESI 7661 proceeding have been withdrawn.
- Unapproved covered products, including identical, related, or similar products, may not be shipped in interstate commerce as of June 26, 2026.
Obligations
What this law requires
Do not ship in interstate commerce any estrogen-androgen fixed-combination drug product identified in DESI 7661, or any identical, related, or similar product, unless it is the subject of an approved NDA or ANDA.
Confirm that any affected estrogen-androgen fixed-combination drug product, including Syntest D.S. and Syntest H.S. tablets or identical, related, or similar products, has an approved NDA or ANDA before sale or shipment in interstate commerce.