FDA OKs Higher Numbers of Competitive Generic Therapies in Fiscal 2021

The number of FDA approvals of competitive generic therapy (CGT) abbreviated new drug applications (ANDAs) rose sharply in fiscal 2021, according to the latest data from the agency.

“CGT” is an FDA designation for drugs for which there is inadequate generic competition. Usually this means there’s not more than one approved drug for the indication.

In fiscal 2021, the FDA approved 53 ANDAs for CGT. That’s up from 35 in 2020. Applications were up significantly too. The number of CGT applications received throughout the fiscal year was 507, up from 390 in 2020.