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FDA Plans To Publish 'Novel' OTC Switch NPRM In May 2020

Executive Summary

Agency list in HHS Unified Agenda also states intent to publish before end of 2019 an NPRM to add the common cold indication to certain OTC monograph antihistamine ingredients. Nonbinding timelines also included for NPRM on clarifying regarding when studies to evaluate drug uses of products marketed as foods, supplements or cosmetics are subject to IND reviews.

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FDA approved sNDAs from GlaxoSmithKline for diclofenac-containing Voltaren Arthritis Pain for the temporary relief of arthritis pain and from Alcon for Pataday olopatadine drops at 0.2% concentration for once-daily use temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander and 0.1% for twice-daily use for the same indications plus redness relief.

US Health Market In 2019: Unfinished Business Leaves Lasting Impression

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.

Final OTC Sunscreen Monograph Postponed, FDA Leadership Confirms

The US FDA is still working through more than 20,000 comments on its February proposed rule to establish a final OTC sunscreen drug monograph. Thus, it will not meet the 26 November 2019 deadline set by the Sunscreen Innovation Act of 2014, said Theresa Michele, director of FDA’s nonprescription drug division, during a 21 November public meeting with industry advocates.

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