FDA Pulls Plug on 1970s Hormone Combo Tablets at Last
Published Date: 5/27/2026
Notice
Summary
The FDA just announced that certain estrogen-androgen combo drugs, like Syntest D.S. and Syntest H.S., aren’t proven effective and can’t be sold unless they have official approval. This affects drug makers and sellers who must stop interstate shipments of these products by June 26, 2026. If you’re involved, it’s time to get compliant or say goodbye to these meds on the market!
Analyzed Economic Effects
2 provisions identified: 0 benefits, 1 costs, 1 mixed.
Manufacturers Must Stop Interstate Shipments
If you make or sell estrogen-androgen fixed-combination drugs (including Syntest D.S., Syntest H.S., Estratest, and Estratest HS, and any identical, related, or similar products covered by DESI 7661), you cannot ship them in interstate commerce unless they are the subject of an approved NDA or ANDA. That prohibition is unlawful to violate as of June 26, 2026, and FDA says it will take enforcement action without further notice against firms that continue to manufacture or ship unapproved products.
Users May Lose Access; Products Found Ineffective
The FDA found that estrogen-androgen fixed-combination products covered by DESI 7661 are not shown to be effective for the labeled menopausal use and cannot be legally shipped without FDA approval. If you take Syntest D.S., Syntest H.S., Estratest, Estratest HS, or a similar unapproved product, you may face reduced availability of those medicines after June 26, 2026, while the safety/effectiveness status and approval are resolved.
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