While it has been June gloom in California, when the gray marine layer forms over the Pacific Ocean and it stays cloudy on the beaches (especially in the mornings) for most of the month, it looks like the coast was clear in Bethesda, Maryland as the OGD unofficially issued 66 full-approval actions and 20 tentative-approval actions for a total of 86 ANDA approval actions. This is highest total for both full- and tentative-approval actions thus far this fiscal year.
This was another strong month for OGD full-approval actions and it represents the second highest month of FY 2025, standing proudly behind December’s 67. The 66 full-approval actions were driven by a period of Orphan Drug Exclusivity for Prucalopride, which is a generic equivalent for for Motegrity, a serotonin-4 (5-HT4) receptor agonist indicated in the treatment of chronic idiopathic constipation (CIC) in adults. The 13 separate ANDAs that received full approval for Procalopride on June 24, 2025, was after the first generic approval of Novitium Pharma LLC’s ANDA on December 24, 2004. Novitium’s ANDA was awarded a 180-day Competitive Generic Therapy exclusivity period which precluded FDA from approving any other ANDA until June 2025.
While the number of full ANDA approvals continues to be strong, ANDA receipts have been a worry, with a potential for the lowest number of ANDA receipts in any fiscal year of modern times (even before GDUFA). We will report more on the June ANDA receipts when the FDA releases the official statistics in the next couple of months.
