FDA Rejects Preterm Birth Drug From Watson, Columbia

Law360, New York (February 27, 2012, 7:09 PM EST) -- The U.S. Food and Drug Administration rejected an application from Watson Pharmaceuticals Inc. and Columbia Laboratories Inc. on Monday for a progesterone drug intended to reduce the risk of preterm birth, concluding the drug's effect was not statistically significant enough to merit approval.

Watson and Columbia announced the findings in a release Monday, saying the companies received a response letter from the FDA detailing the decision. The agency questioned the efficacy of the drug's trial and stated that more clinical work would need to be done...
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