US OTC Decisions In June: Third Tentative Approval For Omeprazole Delayed Release ANDA, More Esomeprazole PPI Final Approvals

 
• By Malcolm Spicer

FDA told P&L Development, as it had with Aurobindo Pharma and Hetero Drugs, that its ANDA for a generic of Prilosec OTC delayed release is tentatively approved because exclusivity has not expired for Perrigo's first-approved generic of the PPI.

Omeprazle prgo
Perrigo's OTC omeprazole 20-mg delayed release tablets remain the only generic-equivalent competition to Prilosec OTC as the number of tentatively approved ANDAs for the formulation grew to three in June.

Editor's note: HBW Insight’s ongoing feature provides information on decisions during June by the US Food and Drug Administration on new drug applications, including ANDAs, for nonprescription drugs and on supplemental NDAs about label and package changes for approved OTC products.

The number of OTC omeprazole 20-mg delayed release tablet products with tentative approval in the US to begin manufacturing following...

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