Columbia Laboratories Inc. CBRX today confirmed that the U.S. Food
and Drug Administration (FDA) has denied Watson Pharmaceuticals' WPI
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.
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