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Imports barred from India's biggest drug firm

September 17, 2008|From the Associated Press

WASHINGTON — The government closed U.S. borders Tuesday to more than 30 generic drugs -- including popular antibiotics and cholesterol medicines -- made by India's biggest pharmaceutical company, citing poor quality in two of its factories.

The Food and Drug Administration's move doesn't end U.S. sales by Ranbaxy Laboratories Ltd. Instead, it blocks imports of generic drugs -- including generic versions of the antibiotic Cipro and the cholesterol pill Zocor -- as well as pharmaceutical ingredients made at the suspect plants.

FDA inspections this year found violations that could lead to contamination, allergic reactions and other problems, and the company hasn't taken proper steps to correct them, said Deborah Autor, director of the FDA's compliance office.

Also, the FDA said it wouldn't approve any new products for sale by Ranbaxy until the manufacturing violations were corrected.

Concern about Ranbaxy has been growing since the FDA uncovered quality problems at one of its plants in 2006.

Yet the FDA told consumers who have Ranbaxy products at home not to worry or quit using them; repeated testing hasn't found any contaminated products, just the threat of them if factory conditions don't improve. Also, it would be hard for a patient to tell whether drugs were made at one of Ranbaxy's factories that follows FDA rules or at the two in trouble.

Among the blocked drugs: the antibiotics ciprofloxacin and clarithromycin, the antiviral acyclovir, cholesterol-lowering simvastatin and pravastatin, and the diabetes drug metformin.

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