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news.The FDA has requested that Cipher Pharmaceuticals provide more evidence regarding its new formulation acne medication isotretinoin, before it will clear the drug for sale.
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The FDA indicated that Cipher’s application is approvable subject to the resolution of two remaining issues. In addition to one question related to chemistry, manufacturing and controls, the FDA has requested that Cipher provide additional clinical data.
Cipher believes that the clinical question raised has been adequately addressed in the submission, and the company will appeal the position taken by the FDA using the formal dispute resolution process.
Cipher received an approvable letter from the FDA in May 2006 and submitted its response in October 2006.