MAP Pharmaceuticals (MAPP) says the FDA has issued a Complete Response letter to its New Drug...
Monday, March 26, 2012, 8:40 PM ETMAP Pharmaceuticals (MAPP) says the FDA has issued a Complete Response letter to its New Drug Application for Levadex. The FDA didn't cite clinical safety or efficacy issues, nor request any additional clinical studies be conducted prior to approval. It did however, request the company address issues relating to chemistry, manufacturing and controls and observations from a recent facility inspection of a third party manufacturer. Shares +7% AH.
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