Clarus Therapeutics files Rextoro at FDA for Testosterone Deficiency

Clarus Therapeutics, Inc., on 13 January 2014 announced the submission of a New Drug Application (NDA) for Rextoro (formerly CLR-610), the Company�s oral testosterone (T) replacement product, to the FDA. Efficacy consistent with the current FDA mandate for T-replacement products was achieved in two Phase III studies. After protocol-prescribed dose titration, at least 75% of men treated with Rextoro achieved average serum T levels (C-avg) in the normal range (between 300 � 1,000 ng/dL).