Issue Date: March 2, 2009
FDA Takes More Action Against Ranbaxy
FDA has stopped reviewing drug applications from a facility owned by India's generic drug company Ranbaxy Laboratories because of concerns that it falsified data and test results on applications for dozens of its products. That facility, Ranbaxy's Paonta Sahib plant, and two other facilities owned by the company have been under an FDA import alert since September for violating current Good Manufacturing Practices. As a result of that previous action, 30 generic drugs manufactured by the Ranbaxy facilities are prohibited from being imported into the U.S. But of concern now are a few generic drugs tested by the Paonta Sahib plant and manufactured in the U.S. FDA has asked Ranbaxy to implement a "corrective action operating plan," including an independent third-party audit of all drug applications associated with the Paonta Sahib facility. "Companies must provide truthful and accurate information in their marketing applications," Janet Woodcock, director of FDA's Center for Drug Evaluation & Research, said in a statement. Despite questions about the integrity and reliability of Ranbaxy's data, FDA says it has no evidence that the drugs are harmful and recommends that patients continue taking them.
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