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Tentative approval for AIDS drugs
Staff Correspondent
NEW DELHI:
The United States Food and Drug Administration (FDA) has given a `tentative' approval to two applications for nevirapine tablets manufactured by Ranbaxy Laboratories (Gurgaon) and the Hyderabad-based Aurobindo Pharma, used for treatment of Acquired Immuno-Deficiency Syndrome (AIDS).
These are the first generic versions of Viramune tablets manufactured by Boehringer Ingelheim and will now be available for purchase under the U.S. Presidents' Emergency Plan for AIDS Relief (PEPFAR).
Nevirapine is in the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which helps keep the AIDS virus from reproducing. This antiretroviral drug is used in combination with other antiretroviral agents for the treatment of HIV-I infection.
The FDA's tentative approval means that although the existing patents or exclusivity prevent the marketing of Aurobindo's and Ranbaxy's products in the U.S., these products meet all of FDA's quality, safety and efficacy standards required for marketing there.
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