PEPFAR Suspends Funding For Three Ranbaxy AIDS Drugs Banned By FDA

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 29 Sep 2008 - 12:00 PST

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The President's Emergency Plan for AIDS Relief program has suspended funding for three antiretroviral drugs manufactured by Indian generic drugmaker Ranbaxy that were included in an importation ban imposed by FDA on Sept. 16, Bloomberg reports. FDA sent letters to the company last week warning of a number of violations at Ranbaxy's manufacturing plants in Paonta Sahib and Dewas, India, including inadequate sterilization processes and inaccurate record-keeping. FDA has banned the importation of more than 30 generic drugs made at those plants, including the three antiretroviral drugs manufactured at the Paonta Sahib plant -- zidovudine, lamivudine and nevirapine. In a statement, FDA said that there is no evidence that the banned drugs are harmful, but violations at the plants could lead to defective drugs, Bloomberg reports. Ranbaxy drugs made in other facilities are not banned.

PEPFAR suspending funding for the Ranbaxy antiretroviral drugs used overseas to "meet standards equal to those established for patients" in the U.S., a program spokesperson said. The PEPFAR suspension means the program no longer will support new orders for the three drugs from the three Ranbaxy plants. The House Energy and Commerce Committee is investigating the safety and effectiveness of Ranbaxy AIDS drugs supplied through PEPFAR. Ranbaxy spokesperson Charles Caprariello said the company is working with the U.S. government "to resolve all of the issues and concerns that have been raised" (Blum, Bloomberg, 9/25).

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