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OTC Decisions In March: Lumify Single-Use, Aleve Arthritis-Grip Cap Labeling, And More Prilosec, Mucinex Copies

 
• By Malcolm Spicer

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.

OTC Regulatory Decisions Tracker US

Editor's note: With information on March 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.

Additional entrants in the OTC guaifenesin and pseudoephedrine expectorant and allergy product and the omeprazole proton pump inhibitor categories are among the US nonprescription drug application approvals during March.

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