Watson, Columbia CRL Could Be Game Changer, Company Official Says

March 7, 2012
In a regulatory rejection decried as a potential industry game-changer, Columbia Laboratories and Watson Pharmaceuticals have received a complete response letter from the FDA for their progesterone vaginal gel citing a lack of agency confidence in Columbia’s sole late-stage trial. The letter left the door open for the sponsors to move forward on additional trials, but “there were some new requirements … that hadn’t been imposed before,” Watson CEO Paul Bisaro said Feb. 27 at the Citi 2012 Global Healthcare Conference in New York.
Washington Drug Letter