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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