Perrigo Gains US Approval For OTC Guaifenesin/Pseudoephedrine Manufacturing
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.
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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.
OTC Decisions In March: Lumify Single-Use, Aleve Arthritis-Grip Cap Labeling, And More Prilosec, Mucinex Copies
Total of CDER decisions during March on OTC applications was down from January and February and also were less substantial for the marketplace. After approving OTC switches in first two months, March decisions for newly available OTCs were limited to additional guaifenesin/pseudoephedrine and omeprazole products offered as private label/store brand alternatives to brands.
Perrigo's first OTC drug approved in 2018 is extended-relief guaifenesin 1,200 mg and dextromethorphan 60 mg tablets, planned for launch under its own store brand, Goodsense, as well as distribution for retailer and private label brands. It already distributes the product for store and private label brands through an agreement with Teva.