We last posted on Competitive Generic Therapy (CGT) approvals in the beginning of April (here) when the Office of Generic Drugs reported 80 approvals for CGT ANDAs. In its latest report (here), that number has jumped to 90, with the approval of ten (10) additional ANDAs approved through the CGT program.
Of the ten (10) new approvals, only one (1) so far has been launched, which triggers the CGT exclusivity. And, quite interestingly, only five (5) of the ten (10) products are reported to be eligible for CGT exclusivity, meaning that while they may have been designated as a CGT product at time of submission, they were no longer eligible at the time of approval. Explanations for eligibility forfeiture and other issues can be found at the updated URL for CGT products above.
