American Generics Laboratories has launched four new ephedra-containing weight-loss supplements "as a result of high consumer demand following the recent overturning of the 2004 FDA ban on ephedra-based products," according to an announcement Nov. 16. The Salt Lake City, Utah-based firm was founded in August and is marketing Superdrine RX-10, Ripped Power, Metabothin and Super Ephedra Extreme online for $39.99 - $59.99. "The products are manufactured in FDA-approved facilities and are of daily dosages permitted by law," the firm maintains. FDA banned dietary supplements containing ephedrine alkaloids in 2004. However, a Utah District Court overturned the ban in April for Nutraceutical Corporation's 10 mg product. FDA is appealing the court's decision (1"The Tan Sheet" Nov. 14, 2005, p. 4)...
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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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The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.
While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.