Adhesive failure and other problems associated with Aveva Drug Delivery Systems' OTC nicotine replacement therapy patches prompt an FDA warning letter on good manufacturing practices violations at the firm's manufacturing facility. In the May 21 letter, FDA said it found GMP violations in an Oct. 22-Dec. 4, 2009 inspection that cause Miramar, Fla.-based Aveva's OTC Nicotine TDDS products to be adulterated. The letter, posted on FDA's website June 8, said Aveva did not determine whether problems with the adhesive and sealant in the products affected the potency of the drug ingredients. Aveva recalled 27,456 14-count boxes of an OTC NRT patch in January 2010 after determining the product was out of specification for the myosmine and beta-nicotyrine degradant ingredients (1"The Tan Sheet" March 22, 2010, FDA Recalls). The firm "needs to explain the correlation between excessive potency failure and adhesive roll laminate properties," FDA said. Aveva received 570 complaints from August-October 2009 about NRT patch adhesive, according to the letter, which also says the firm did not follow written procedures for handling complaints
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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.