Research Firm Asks FDA To Clear Path For Generic Fosamax

Law360, New York (July 3, 2014, 4:25 PM EDT) -- Research firm Clinipace Worldwide has recently asked the U.S. Food and Drug Administration in a citizen petition to issue a finding that Merck & Co. did not discontinue the drug Fosamax for health and safety reasons, seeking to clear the way for new generic versions of the osteoporosis drug. 

If the FDA determines the drug was not discontinued for those reasons, the June 20 petition, which was submitted on behalf of an unidentified Clinipace client, asks the FDA to accept an abbreviated new drug application for a generic version of the drug.

“Under FDA regulations, the agency must make a determination as...

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