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
You may also be interested in...
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...
Schering Sales Force Recruitment Is 80% Complete; Morale Remains High
Recruitment for Schering-Plough's sales force expansion is 80% complete, Global Pharmaceutical President Carrie Cox told investors during a year-end conference call Jan. 26