Nonoxynol-9, octoxynol-9 NDAs require efficacy data only -- FDA guidance.
This article was originally published in The Tan Sheet
Executive Summary
NONOXYNOL-9, OCTOXYNOL-9 NDAs REQUIRE EFFICACY INFORMATION ONLY, according to a guidance document covering the development of NDAs for OTC vaginal contraceptives. The document, called "Guidance for Development of Vaginal Contraceptive Drugs," was published in the Feb. 3 Federal Register along with the OTC vaginal contraceptives tentative final monograph. The TFM requires that NDAs or ANDAs be submitted for all OTC vaginal contraceptives.
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