Drug Co-Packaging Proposed Rule Could Hamper Some OTC Marketing
OTC drug packages with separate containers of a product's daytime and nighttime formulations could be mislabeled under US FDA’s proposed rule, as well as co-packaged products with little similarity in use, such as an oral analgesic sold in tandem with a topical pain relief product.
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House subcommittee approves DXM Abuse bill; UK ire for US firm’s patch claims; Innophos VP hire; and more news in brief.
Latest warnings also include second and third businesses in US cannabidiol and hemp sector found making unlawful claims for treating and preventing COVID-19. Four of five firms warned apparently responded by removing violative claims from websites and social media posts.
OTC Decisions In March: Lumify Single-Use, Aleve Arthritis-Grip Cap Labeling, And More Prilosec, Mucinex Copies
Total of CDER decisions during March on OTC applications was down from January and February and also were less substantial for the marketplace. After approving OTC switches in first two months, March decisions for newly available OTCs were limited to additional guaifenesin/pseudoephedrine and omeprazole products offered as private label/store brand alternatives to brands.