FDA on July 2 approves Taro Pharmaceutical U.S.A's application for a generic version of Novartis' OTC athlete's foot cream Lamisil AT (terbinafine hydrochloride, 1 percent). Taro's product will be the first generic Lamisil cream on the market, according to FDA. The firm was granted tentative approval in March 2006 (1"The Tan Sheet" March, 27, 2006, p. 11). Novartis recently introduced a gel form, Lamisil AT Gel Advanced, which "cures most athlete's foot with 1/2 the applications of any other product," according to the product Web site. FDA also approved the first generic versions of Rx Lamisil tablets as the remaining patent or exclusivity for the drug expired June 30...
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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.’
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.
Average sales prices, and Medicare spending on some drugs, would be expected to be lower, CMS says in the Physician Fee Schedule proposed rule.
