Expert Pharmacy Insights

Diane-35 in the USA: Why It Isn't FDA-Approved, What It Treats, Clot Risk and US Alternatives

Diane-35 combines cyproterone acetate 2 mg with ethinylestradiol 35 micrograms for acne and hirsutism in women. It is prescribed in Canada, the UK, Australia and India but has never been FDA-approved. This guide covers its licensed uses, trial results, the 2013 European review, blood clot risk against other pills, the 2020 meningioma review, who should not take it, and FDA-approved US alternatives.