GSK’s Proposal For Mouth Spray Nicorette Delayed By FDA Questions On Label
Glaxo plans to make changes FDA requested in Complete Response letter sent on 18 October, the agency’s deadline for acting on NDA for an oral spray that delivers 1 mg per spray of aqueous buffered nicotine solution for oromucosal use.
You may also be interested in...
CRLs FDA submits in response to ANDAs increased most years since FY 2015, though FY 2020 total likely will be lower than two previous years. A 2019 CRL interrupted GSK's plans to market first mouth spray nicotine replacement therapy in US.
FDA warns Smart Toothpicks about selling nicotine-infused toothpicks to a minor and its online claim, "nicotine satisfaction without smoke damage to your lungs.” Escaping FDA attention so far are a dry mouth claim and a B12 formulation.
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.