- Repros Therapeutics (NASDAQ:RPRX) submits a complete response to the FDA's guidance concerning the documentation for its New Drug Application (NDA) for Androxal (clomiphene citrate). The company believes that all questions have been addressed and expects its contract research organization (CRO) to file the NDA in Q1.
- The company has engaged a European regulatory consultant to assist with converting the Androxal NDA to a suitable Marketing Authorization Application (MAA) for clearance in Europe. It expects to file the MAA by Q1 2016.
- Previously: Repros jumps after FDA meeting on Androxal NDA (Nov. 7)
- Previously: Repros gets roughed up after FDA downgrades meeting (Oct. 17)