Complete Response Letters
Chemo Research, S.L.: dienogest
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, May 29, 2025
1. Review of the safety database from Study LPRI-424/303 clearly demonstrates a markedly increased risk of venous thromboembolism (VTE) rate.
CRL_NDA219029_20250529:p1:s15A higher VTE rate associated with the same dienogest and ethinyl estradiol (DNG/EE) combination as your proposed product as compared to other combination oral contraceptives (COCs) in the European postmarketing database further substantiates an increased risk of your proposed fixed dose combination product.
CRL_NDA219029_20250529:p1:s16We are unable to recommend any further actions that would result in approval of this application.
CRL_NDA219029_20250529:p1:s19More Complete Response Letters
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