In a statement, FDA commissioner Scott Gottlieb, M.D. announces a new pathway for accelerated view of marketing applications from generic drugmakers for off-patent branded medicines facing no generic competition, a situation characterizing "hundreds" of such drugs that serve small patient populations and/or are difficult to copy due to their complexity.
The designation, called Competitive Generic Therapies (CGT), provides for more intensive FDA guidance on development as well as a shorter review clock. An approved abbreviated new drug application (ANDA) for a CGT-tagged generic medicine will also enjoy a 180-day period of market exclusivity (no real change here since this is the same exclusivity period for an approved "first-to-file" application).
Dr. Gottlieb says the agency has signed off on 100 CGT requests to date with five ANDAs approved in 2018 (August - December).
Subscribe for full text news in your inbox