Sweden’s Enorama Looking To Break Into US And Europe’s Crowded NRT Markets
HBW Insight speaks to Swedish R&D firm Enorama's vice president Annette Agerskov about the company's plans to enter US and European OTC nicotine replacement therapy markets with a new, consumer-friendly nicotine gum.
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CDER representative says staff’s time available for drug applications currently is affected by the FDA having employees work remotely in response to the novel coronavirus pandemic.
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.
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.