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An FDA final rule rejects generally regarded as safe and effective status for 24 OTC monograph antiseptic ingredients regarding products intended for use by health care professionals in hospitals or similar venues. However, six ingredients on which FDA deferred its decision also are used in consumer antiseptic washes, which GRASE decisions pending in separate rulemakings.
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Many CHPA members also market medical devices "and the consumer side of medical devices is something they feel is underrepresented by other trade associations,” says trade group head Scott Melville. OTC drugs already have “a lot in common” with consumer medical devices, including that paying for neither typically is included in health insurance plans.
Commissioner Gottlieb has been a “very strong champion” of FDA and his interest in improving the OTC monograph and switch processes provides hope to the industry during a tumultuous legislative era, say CHPA executives at their annual meeting in Florida. They expect monograph reform will happen this year but doubt much else will happen before mid-term elections in November.
OTC switch sponsors should identify adversaries early in the application switch process so they can counter arguments that could derail their switch, s consultant advises. Some switches fail because firms target regulatory approval and do little on marketplace performance.
Randob Labs agreed to purchase the Balmex brand of baby and adult skin protectants from Moberg Pharma for $4.25m. Mission Pharmacal divested to MainPointe topical analgesic brand Thera-Gesic and the Dr. Smith’s line of infant and adult skin protectant ointments and sprays.
Perrigo's first OTC drug approved in 2018 is extended-relief guaifenesin 1,200 mg and dextromethorphan 60 mg tablets, planned for launch under its own store brand, Goodsense, as well as distribution for retailer and private label brands. It already distributes the product for store and private label brands through an agreement with Teva.
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