Columbia Laboratories Confirms FDA Denies Watson's Appeal Related to Prochieve NDA for the Prevention of Preterm Birth

Columbia Laboratories Inc.

today confirmed that the U.S. Food and Drug Administration (FDA) has denied Watson Pharmaceuticals'

Formal Dispute Resolution Request (FDRR) related to its New Drug Application (NDA 22-139) for Prochieve for the prevention of preterm birth in women with a short cervical length. Watson said it intends to review possible options related to the continued pursuit of the NDA. Watson filed its FDRR in August of 2012.