FDA adds priority ANDA review category

As part of FDA Commissioner Scott Gottlieb's ongoing effort to promote competition, FDA created a new category for ANDAs that the agency will prioritize. The category encompasses applications likely to be ready for approval upon or shortly after the expiration of the 180-day exclusivity period that is awarded to a first-to-file generic drug application.

FDA said the addition is part of the agency's Drug Competition Action Plan, which aims to support generic competition, and follows a public meeting held in July to discuss administration of the Hatch-Waxman Act. At the meeting, attendees proposed ways to reduce anticompetitive practices and accelerate generic drug approval. Gottlieb said at the meeting that FDA planned to issue guidance to increase the efficiency of the ANDA review process (see BioCentury Extra, July 18)...