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.’
England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.
Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.
