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