FDA Removes Teeth From Exclusivity Forfeiture

Law360 (January 24, 2008, 12:00 AM EST) -- On Jan. 17, 2008, the Food & Drug Administration (“FDA”) issued a letter ruling that the forfeiture provisions added to the Hatch-Waxman Act by the 2003 Medicare Modernization Act (the “MMA”) do not require the generic exclusivity holder to forfeit its exclusivity if more than 30 months have passed since the generic company filed its Abbreviated New Drug Application (“ANDA”).

Specifically, FDA determined that Teva Parenteral Medicines Inc. (“Teva”) had not forfeited its 180-day generic exclusivity period relating to granisetron when it failed to market its...
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