February 25, 2009 / 5:01 PM / 10 years ago

UPDATE 3-US FDA says Ranbaxy plant falsified data

 (Adds Ranbaxy comment, details from FDA)
 By Lisa Richwine
 WASHINGTON, Feb 25 (Reuters) - A plant owned by Indian generic drugmaker Ranbaxy Laboratories RANB.BO falsified data and test results submitted in approved and pending drug applications, U.S. regulators said on Wednesday.
 The Food and Drug Administration said it halted reviews of drug applications from Ranbaxy’s Paonta Sahib plant in India.
 Agency officials said they had not identified any health risks from Ranbaxy drugs on the market, but were continuing to investigate products associated with the plant.
 “The FDA’s investigations revealed a pattern of questionable data raising significant questions regarding the reliability of certain applications,” said Deborah Autor, director of compliance in the agency’s drug center.
 The action applies to about 25 approved drug applications that contain data from the plant, Autor said. The move “has limited significance for U.S. marketed products” because the FDA banned most of the drugs when it blocked imports from the facility in September due to manufacturing problems, she said.
 Patients should not stop taking Ranbaxy drugs but consult a doctor if they are concerned, FDA officials said.
 Ranbaxy, India’s largest drugmaker by sales, said it would continue to cooperate with the FDA.
 “No effort or action will be spared to timely protect key (generic drug applications) from Paonta Sahib,” the company said in a statement.
 Ranbaxy said some of the applications are “first-to-file” applications, which can win 180 days of market exclusivity if approved.
 In September, the FDA banned more than 30 generic drugs from entering the United States that were made at Ranbaxy plants in Paonta Sahib and Dewas, India. The drugs included cholesterol-lowering drugs, AIDS medications and antibiotics.
 The FDA’s Autor said several years of investigation showed Ranbaxy failed to conduct shelf-life tests at appropriate intervals and submitted false information about when the tests were done and how the drugs were stored.
 She said she could not comment on how many pending drug applications were affected.
 The agency said it had asked Ranbaxy to help resolve questions about data integrity and reliability for drugs made at the plant plus three other medicines that were backed by information from the site but now are produced in New Jersey.
 Plans for correcting the problem should include a third-party audit, the FDA said.
 Japanese drugmaker Daiichi Sankyo (4568.T) holds a controlling stake in Ranbaxy.  (Reporting by Lisa Richwine and Susan Heavey, editing by Tim Dobbyn, Matthew Lewis and Leslie Gevirtz)   

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