Forfeiture of 27 ANDAs is a small piece of Ranbaxy penalties

A new posting in the Federal Register officially withdraws 27 approved abbreviated new drug applications from Ranbaxy Laboratories, a forfeiture that was written into the consent decree with the Department of Justice and the FDA, as announced in December. The news initially smacked the company's shares but after analysts determined that it was a sign of issues over its consent decree being up, today they hit a 52-week high. In a statement made Wednesday, the Indian generics maker explained that the products had a "negligible commercial impact" on Ranbaxy. Under the decree, Ranbaxy can never again make the 27 drugs but it had lived several years with 30 drugs on an import ban list. The forfeitures are a small part of what Ranbaxy gave up to satisfy regulators after it was caught faking data to the FDA and using substandard operations at three plants. It also lost the 180-day exclusivity on three undisclosed drugs, and agreed to a long list of third-party oversight, with the cost for the consultants coming out of its own pocket, or that of parent Daiichi Sankyo. The Japanese company set aside $500 million to help cover the costs, while the charge led Ranbaxy to a $600 million fourth-quarter loss. Federal Register announcement (PDF) | More

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