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Expert Analysis

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")....

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