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.
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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.
Bausch reported global sales of Lumify eye drops, PreserVision supplements and other consumer health products up 8.9% to $353m. However, its net loss grew to $152m from $52m in the year-ago period on a $65m dent in its income due to mass postponements of ocular and dermatologic surgeries.
OTC Decisions In February: 2 Switches, Label Changes For Excedrin, FeverAll, Naproxen From Biopharma
FDA approved two switches on one day in February, diclofenac gel and olopatadine ophthalmic drops, and stayed busy on OTCs through the month with label changes for Excedrin Migraine packaged with 2-count pouches and for Taro's FeverAll suppositories, and an NDA approval for Biopharma's naproxen.