The U.S. Food and Drug Administration (“FDA”) Reproductive Drugs Advisory Committee (“RDAC"; the “Committee”) today discussed and voted on six topics surrounding the potential approval of 17a hydroxyprogesterone caproate (“17-OHPC”) for the prevention of recurrent preterm birth. While the recommendations of the Committee to the FDA were both favorable and unfavorable on 17-OHPC, its opinion was clear on two points of significance to Columbia Laboratories (NASDAQ: CBRX) and PROCHIEVE(R) 8% (progesterone gel), the Company’s investigational candidate for the prevention of recurrent preterm birth.
