Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.
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Wall Street Journal - September 17, 2008
Alicia Mundy, alicia.mundy@wsj.com; Jared A. Favole, jared.favole@dowjones.com; and Shirley S. Wang, shirley.wang@wsj.com
The U.S. Food and Drug Administration banned imports of more than 30 generic drugs made by India's Ranbaxy Laboratories Ltd., citing concerns about the safety of the company's production practices.
The ban affects low-cost versions of popular medicines such as the anticholesterol drug Zocor; Acyclovir, which treats herpes; the heartburn pill Zantac; and AIDS drugs. Consumers shouldn't be affected by a medicine shortage because the drugs can be supplied by other generics makers, the agency said.
The agency said it acted because of concerns about the "seriousness and extent" of violations of manufacturing standards at two Ranbaxy plants in India. The agency said it hasn't found safety problems in drugs in the U.S.
But agency officials said they are concerned about whether the drug maker's practices can ensure purity of drugs from these facilities. Even so, FDA officials said patients shouldn't stop taking needed medicines.
A Ranbaxy executive in India said the company didn't know of any FDA action and officials in the U.S. didn't return calls. The agency said it had notified Ranbaxy of the import restriction.
Ranbaxy is India's biggest drug maker by sales and among the world's biggest generic-drug makers. It had world-wide sales of $1.62 billion in 2007, with nearly $400 million in the U.S. Tokyo-based Daiichi Sankyo Co. has made a bid to take over the company in a $4.6 billion deal that is awaiting Indian government approval.
The FDA said it will allow Ranbaxy to continue to ship a key AIDS drug called Ganciclovir in order to avoid a shortage. Ranbaxy is the sole supplier of that drug in the U.S. The FDA also said it won't approve any drug applications that list the two suspect Ranbaxy plants as a source of ingredients.
Ranbaxy also is under investigation by the U.S. Justice Department into whether it manufactured substandard generic drugs, including allegations that it improperly manufactured HIV drugs that were given to thousands of AIDS patients in Africa.
The FDA is under fire from U.S. lawmakers who have said it acted too slowly against Ranbaxy. The agency found quality problems in February 2006 during an inspection in India, but until recently officials said they didn't believe the deficiencies justified an import alert.
Geeta Anand contributed to this article.
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