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Ribavirin ANDAs Await ICN Petition; FDA Generic Rule Takes Effect

Executive Summary

The delay in approval for generic versions of Schering-Plough's Rebetol (ribavirin) illustrates one limitation of FDA's revised Waxman/Hatch regulations

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Orange Book patent listings

FDA's Office of Generic Drugs records a 36% drop in "Orange Book" patent listings since FDA's revised Waxman/Hatch regulations took effect in August 2003. The rule, which was codified in the 2003 Medicare Modernization Act, permits only one 30-month stay of approval on ANDAs (1"The Pink Sheet" Aug. 18, 2003, p. 17). For the year prior to the rule's enactment (Aug. 18, 2002 to Aug. 18, 2003), the number of distinct new listed patents was 383; for the following 12 months, listings fell to 245 patents. "It's too soon to make definitive conclusions about" MMA and the generic drug regulations, "but I can tell you that from my standpoint...they're working well," FDA Acting Commissioner Lester Crawford told the Generic Pharmaceutical Association's annual meeting...

Orange Book patent listings

FDA's Office of Generic Drugs records a 36% drop in "Orange Book" patent listings since FDA's revised Waxman/Hatch regulations took effect in August 2003. The rule, which was codified in the 2003 Medicare Modernization Act, permits only one 30-month stay of approval on ANDAs (1"The Pink Sheet" Aug. 18, 2003, p. 17). For the year prior to the rule's enactment (Aug. 18, 2002 to Aug. 18, 2003), the number of distinct new listed patents was 383; for the following 12 months, listings fell to 245 patents. "It's too soon to make definitive conclusions about" MMA and the generic drug regulations, "but I can tell you that from my standpoint...they're working well," FDA Acting Commissioner Lester Crawford told the Generic Pharmaceutical Association's annual meeting...

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