For each of the last five years, the US Food and Drug Administration (FDA) has set generic drug approval records, but questions have lingered on whether these high approval numbers are translating into competition. FY 2019 figures show a total of 1,171 generic drug approvals (935 full approvals and 236 tentative approvals), which breaks FDA’s previous all-time record of 971 full and tentative approvals for FY 2018 . And although the abbreviated new drug application (...

Pfizer, Perrigo, Teva, Apotex and the Association of Accessible Medicines all sought further clarity from the US Food and Drug Administration (FDA) on draft guidance related to the competitive generic therapy (CGT) designation and CGT exclusivity. The CGT designation is meant to be an incentive for industry to develop generics for drugs that have only one competitor. To date, FDA has granted more than 100 CGT designation requests, and in 2018, between August and Decembe...

The US Food and Drug Administration (FDA) on Friday released draft guidance providing information on how sponsors can apply for competitive generic therapy (CGT) designation and when they may be eligible for CGT exclusivity. The CGT designation, which was established with the  FDA Reauthorization Act of 2017 (FDARA), is meant as an incentive for industry to develop generics for drugs lacking competition. To date, FDA has granted more than 100 CGT designation reque...