FDA’s Exclusivity Forfeiture Saga Continues

Law360, New York (May 15, 2008, 12:00 AM EDT) -- Just when we were all starting to get a better understanding of the exclusivity forfeiture provisions added to the Hatch-Waxman Act by the 2003 Medicare Modernization Act (the “MMA”), the Food and Drug Administration (“FDA”) has thrown us another curveball.

In its May 7, 2008 letter ruling on Cobalt’s exclusivity period relating to its generic version of Bayer’s Precose (acarbose) tablets, FDA determined that Cobalt had forfeited its exclusivity period under the MMA forfeiture provisions because Cobalt did not obtain final approval of its ANDA within...
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