Complete response for MAP's Levadex could add year to approval: Analyst (WCG's FDAnews) - Apr 6, 2012 - The FDA's complete response letter for MAP Pharmaceuticals' migraine drug Levadex could tack on another year before approval, but the company says the letter should be fairly easy to deal with; The letter asks the company to address some chemistry, manufacturing and controls issues related to processes and process controls
Anticipated market approval • Migraine
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The FDA’s complete response letter for MAP Pharmaceuticals’ migraine drug Levadex could tack on another year before approval, but the company says the letter should be fairly easy to deal with. The letter asks the company to address some chemistry, manufacturing and controls (CMC) issues related to processes and process controls. It also must address observations from a recent inspection of a third-party manufacturer, MAP CEO Timothy Nelson said Tuesday on an investor call.
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