Corin Group Plc won approval to sell its resurfacing system for worn-out hips

MondayMorning, July 9, 2007

FDA ROUNDUP: Corin Group Plc won approval to sell its resurfacing system for worn-out hips. U.K.-based Corin said it will market the implants to patients younger than 65 as an alternative to full artificial hips made by companies such as Johnson & Johnson and Smith & Nephew Plc. Elsewhere, Mylan Laboratories Inc. (Canonsburg PA) was cleared to sell its generic version of Novartis AG's over-the-counter fungus treatment Lamisil. Novartis' patent expired Dec. 30. Several other companies have received either approval or tentative approval for a generic version of the treatment, including Teva Pharmaceutical Industries Ltd. Spectranetics Corp. (Colorado Springs CO) won approval for its TURBO-Booster catheter to treat blocked arteries in the leg. The product works as a guiding catheter to help treat blockages in the main arteries at or above the knee. And Vascular Solutions Inc. (Minneapolis MN) won approval for its Gopher support catheter. The Gopher is designed to assist in the positioning of an angioplasty balloon.

But Altus Pharmaceuticals Inc. (Cambridge MA) said the FDA revoked orphan status for the company's pancreatic insufficiency treatment ALTU-135. The FDA revoked the status, granted in 2002, citing a patient population in the U.S. exceeding the 200,000 person limit. Altus said it may consult with the FDA on whether it should refile the application.