The Hindu Business Line : Tentative USFDA nod for Aurobindo's 3rd AIDS drug

AUROBINDO Pharma Ltd (APL) has obtained the tentative approval of the United States Food and Drug Administration (USFDA) for another anti-AIDS drug Efavirenz, the generic version of Sustiva tablets, manufactured by Bristol-Myers Squibb.

This is the third AIDS drug of Aurobindo to get the USFDA approval in the recent past. The first two drugs are Nevirapine, the generic version of Viramune tablets manufactured by Boehringer Ingelheim GmbH, and Lamivudine, the generic version of Combivir made by GlaxoSmithKline Plc.

Confirming the latest development, the Aurobindo spokesperson told Business Line that Efavirenz falls under the class of drugs called non-nucleoside reverse transcriptase inhibitors (NNRTIs), which helps preventing the AIDS virus from reproducing in cells. In the treatment of HIV-1 infection, Efavirenz is generally used in combination with other antiretroviral drugs.

According to the Aurobindo official, the USFDA's tentative approval implies that the drug meets all the standards prescribed by the regulator such as quality, safety and efficacy for marketing it in the US. However, the drug cannot be sold in the US because of the existing patents and exclusive marketing rights.

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