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OTC Decisions In April: Naproxen CV Risk Warning, Sun US Line Rises, Perrigo Omeprazole 'Melt In Mouth' Flag

 
• By Malcolm Spicer

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.

OTC Regulatory Decisions Tracker US

Editor's note: With information on April decisions, HBW Insight continues our ongoing feature to provide information on decisions 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.

Label warnings for naproxen's interaction with aspirin are being added to OTC products available in the US two years after...

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