FDA Publishes Final Guidance on Competitive Generic Therapies

The US Food and Drug Administration (“FDA”) recently issued a final guidance on the Competitive Generic Therapies (“CGT”) program. The CGT program created a new pathway by which the FDA may designate a drug with “inadequate generic competition” as a CGT. The FDA would do so at the request of an applicant, and may also expedite the review of an Abbreviated New Drug Application (“ANDA”) for a drug in the CGT pathway.

The guidance describes several aspects of the CGT program, including the following:

CGT Designation: A drug may be designated as a CGT if there is a finding of