OTC Decisions Tracker: Dr Reddys NRT Lozenge Approved, Prilosec OTC And Monistat Packaging Revised

HBW Insight introduces an ongoing feature with information on decisions by FDA on NDAs and ANDA for nonprescription drugs and on sNDAs for label and package changes for approved OTC products. Dr Reddys Laboratories' clearance to launch OTC nicotine replacement therapy lozenges in the US and revisions to Prilosec OTC and Monistat packaging were among FDA's s OTC-related decisions in January.

Editor's note: HBW Insight is launching an 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.

The FDA regularly publishes lists of its decisions on applications for new products and label changes across the US market...