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Senate HELP Committee approves an OTC monograph reform bill with two-year market exclusivity for some products. The bill also establishes a user fee program to pay for FDA's work and replaces public rulemakings currently required for any change with an administrative order process.
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FDA has yet to finalize about one-third of its OTC monographs and several hundred ingredients do not have a final GRASE determination. Sorting will help the agency determine which of the 800 active OTC monograph ingredients are designated as needing more information to establish GRASE under a faster system based on administrative orders.
Johnson & Johnson will launch a Listerine mouthwash incorporating a class II device to address tooth sensitivity, Chief Technology Officer John Ghaim said during J&J’s Medical Devices & Consumer Analyst Day May 16. The company plans to launch 150 new products globally in 2018, which should help the company achieve sales ahead of the consumer health category.
Commissioner Scott Gottlieb updates US FDA's initiative to prevent potentially fatal abuse of OTC loperamide, noting that online and conventional retailers are limiting product purchases while the agency continues evaluating the appropriate number of doses per package.
Nonprescription products containing ibuprofen can now only be marketed in the US through NDAs. No companies took advantage of a proposed ibuprofen addition to the the internal analgesic, antipyretic and antirheumatic OTC monograph, issued in 2002.
Carma Labs’ Carmex Cold Sore Treatment claims did not mirror language in two OTC monographs for its active ingredients, the National Advertising Division says in a review of packaging and advertising claims challenged by GlaxoSmithKline's consumer business.
Following enactment of US OTC monograph reform, drug companies will unleash formulation innovations after keeping a lid on monograph R&D, CHPA anticipates. "A lot of companies have ideas like this they’ve kind of put in a drawer, that we think this is gonna unlock,” says David Spangler, an executive with the OTC trade group.
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