Legatrin PM: Columbia Labs soon plans to launch reformulated version of its Legatrin nocturnal leg cramp product. Legatrin PM does not contain quinine but does contain a combination of acetaminophen and diphenhydramine. The product will be promoted for occasional sleeplessness and muscle aches and pains such as those associated with leg cramps, the firm said. FDA banned the use of quinine in leg cramp products in an Aug. 22, 1994 final rule on the product class, effective Feb. 22 ("The Tan Sheet" Aug. 22, 1994, p. 8). Separately, FDA recently sent letters to 44 companies warning that prescription quinine can no longer be sold for leg cramps without an approved NDA or ANDA. The letters follow a Sept. 8, 1994 citizen petition from Public Citizen's Health Research Group requesting such action...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.
Kumar takes over as acting director of the Center for Biologics Evaluation and Research’s Office of Therapeutic Products days after director Nicole Verdun was ousted.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
