FDA Rebuffs Four Drugmakers on Citizen Petitions

The FDA has denied four citizen petitions submitted by law firms representing Warner Chilcott, Medicis Pharmaceutical, Roche and Stiefel Laboratories seeking 30-month stays of approval for generic versions of drugs containing old antibiotics. The brand-drug petitioners were seeking input on whether the QI Program Supplemental Funding Act of 2008 imposed a 30-month stay of approval on an ANDA that included a Paragraph IV certification on certain patents covering drugs that contain an antibiotic approved by the FDA prior to the Nov. 21, 1997, effective date of the FDA Modernization Act.
Drug Industry Daily