OTC Decisions In May: Esomeprazole For Sun Pharma, Guaifenesin For Granules India, More NRTs For PLD During Slow Month For Approvals
CDER representative says staff’s time available for drug applications currently is affected by the FDA having employees work remotely in response to the novel coronavirus pandemic.
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FDA also approves packaging redesign for Mucinex and Mucinex-DM and final changes to labeling text and location on packaging. Granules Pharmaceuticals’ generic of Excedrin Migraine also among CDER’s decisions on OTC ANDAs and sNDAs during January-March.
As the agency and country plot the steps to reopening, a full resumption of activities still seems a long way off.
US FDA approves Bayer HealthCare's supplemental NDA for adding Aleve Headache Pain proprietary name to use with the brand’s regular strength formulation, naproxen 220 mg. The approval also allows moving headache to top of indications list.