Six Indian generic ARVs are given FDA tentative approval

On 27 May 2005, FDA granted tentative approval to Ranbaxy Laboratories, for lamivudine tablets, 150 mg. This was followed a few week later, on 15 June, by tentative approval for generic lamivudine manufactured by Aurobindo Pharma.

On June 20, 2005, two applications for nevirapine (one from Ranbaxy, one from Aurobindo) also received tentative approval.

Four days later the FDA granted tentative approval for efavirenz tablets manufactured by Aurobindo Pharma. This product is the first tentatively approved generic version of efavirenz tablets.

Finally, on 1 July FDA granted tentative approval for d4t (stavudine) manufactured by Aurobindo Pharma.

A Tentative Approval means that FDA has concluded that a drug product has met all of the agency’s quality, safety and efficacy standards required for marketing in the US, even though it may not yet be marketed in the U.S. due to existing patents and/or exclusivity. It does, however, make the product eligible for use under the President’s Emergency Plan for AIDS Relief (PEPFAR) program outside the United States.

An archive of FDA list serve announcements is available on the FDA web site:

Source: FDA list serve

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