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FDA Halts New Applications From Indian Drug Maker's Plant
Date:2/25/2009

Agency says Ranbaxy Laboratories facility falsified scientific data

WEDNESDAY, Feb. 25 (HealthDay News) -- U.S. health officials have halted the review of any new drug applications from a Ranbaxy Laboratories plant in India after determining the facility was falsifying scientific data.

Ranbaxy, based in India, is one of the largest suppliers of generic drugs to the United States.

"We took this action after it became apparent that this facility was submitting falsified scientific data in applications for FDA approval of marketed drugs in the United States," Dr. Douglas Throckmorton, deputy director of FDA's Center for Drug Evaluation and Research, said during a Wednesday teleconference.

Falsifying data in drug applications is a "serious breach of integrity -- a breach that must be quickly addressed and corrected," Throckmorton added.

Throckmorton noted this is the second action against the Paonta Sahib facility in less than six months. "No other Ranbaxy facilities are directly affected by this action," he said.

Until these problems are resolved, the FDA will stop review of drug applications from the Paonta Sahib plant and the agency will not accept any new applications from this plant, Throckmorton said.

These applications fall into three categories, drugs made in the plant for the U.S. market, drugs not marketed in the United States pending FDA approval, and drugs made in the United States that relied on data from the Paonta Sahib plant.

Last September, the FDA denied U.S. entry of 30 generic drugs made at the Paonta Sahib plant and a sister facility in Dewas, India, for problems related to the manufacturing process. At that time, FDA officials also recommended denying any new drug applications from those two plants.

Some of the false data supplied from the Paonta Sahib plant involved the shelf life of products, Deborah Autor, director of the FDA's Office of Compliance at the Center for Drug Evaluation and Research, said during the teleconference. In addition, the company falsified data about production practices, she said.

The agency will begin reviewing applications only after Ranbaxy is able to prove to the agency that all of its data are correct and the FDA no longer has a concern about the data in the applications, Autor said.

While most products made by the company in the United States are not part of the FDA action, Autor added, there are some U.S. products that are affected.

Two of them are cholesterol-lowering drugs, pravastatin (Pravachol) and imvastatin (simvastatin), and an antihistamine known as pheniramine (Avil), Autor said.

The FDA is asking Ranbaxy for assurance that none of the data on these drug applications are from the Paonta Sahib facility, she explained.

Throckmorton was careful to say that the FDA has received no reports of harm caused by Ranbaxy products made in the United States or in the Paonta Sahib plant.

In addition, the agency is advising patients not to stop taking any medications without talking with their doctors first, he said.

More information

For more information on drug safety, visit the U.S. Food and Drug Administration .



SOURCES: Feb. 25, 2009, teleconference with: Douglas Throckmorton, M.D., deputy director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, and Deborah Autor, J.D., director, Office of Compliance, Center for Drug Evaluation and Research, FDA


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