US OTC Decisions In June: Third Tentative Approval For Omeprazole Delayed Release ANDA, More Esomeprazole PPI Final Approvals
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.
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HBW Insight introduces an ongoing feature with information on decisions by FDA on NDAs and ANDA for nonprescription drugs and on sNDAs for label and package changes for approved OTC products. Dr Reddys Laboratories' clearance to launch OTC nicotine replacement therapy lozenges in the US and revisions to Prilosec OTC and Monistat packaging were among FDA's s OTC-related decisions in January.
Perrigo receives approval for its ANDA for a Prilosec OTC equivalent and another for a generic of Advil Fast Relief. The firm includes those products in its outlook for $1 billion in new product sales over three years.
Approval of Alaway Preservative Free (ketotifen fumarate, 0.035) comes 15 months after FDA submitted a complete response letter to Bausch and the active ingredient developer, Eton Pharmaceuticals.