OTC Decisions In April: Naproxen CV Risk Warning, Sun US Line Rises, Perrigo Omeprazole 'Melt In Mouth' Flag
The first US approvals for adding cardiovascular risk warnings to OTC naproxenb products were for the Aleve line of multiple formulations and delivery formats and in multiple container sizes and Biopharma and Catalent 220-mg capsules. Sun Pharma extends into expectorant/allergy and diarrhea remedy spaces in US OTC market.
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Predominant US OTC private label/store brand provider plans commercialize products in second half. Firm has yet to set date to release 2021 full-year and fourth-quarter results.
Approvals by FDA also include revised container and consumer information labeling for J&J's Men’s Rogaine to align with labeling for Women’s Rogaine; bonus-pack labeling for Bayer AG’s Aleve; and
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.