FDA Advisory Committee rejects Rextoro as a treatment for Testosterone Deficiency - Clarus Therapeutics

Clarus Therapeutics, Inc. announced that the FDA Bone, Reproductive and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 18-3 that the overall benefit/risk profile of Rextoro (Testosterone Undecanoate) was not acceptable to support approval for Testosterone Replacement Therapy. The panel also voted 12-8 with one abstention that there was not sufficient evidence that Rextoro is effective.

The FDA is not required to follow the Committee's decision, but will consider its findings during the new drug application (NDA) review of Rextoro. The FDA accepted Clarus Therapeutics' NDA for Rextoro on January 3, 2014 and assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 3, 2014.