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US Health Market In 2019: Unfinished Business Leaves Lasting Impression

 
• By Malcolm Spicer

Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.

HBW Insight perspectives 2019 to 2020

The US OTC drug industry and the Food and Drug Administration could look back on 2019 as a year that started with great promise but ended with little to show for products that expanded the market and regulatory milestones that made more expansion more likely.

Exhibit A for the sector’s 2019 performance could be GlaxoSmithKline PLC receiving a Complete Response letter from the FDA on its proposal to market the first mouth spray nicotine

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