The Hindu Business Line : Aurobindo gets tentative USFDA nod for AIDS drug

Aurobindo Pharma Ltd has announced that the United States Food and Drug Administration (USFDA) has granted tentative approval for Abacavir Sulphate tablets 300 mg (base).

In a press release here on Tuesday, the company said this is the first generic version approval given by the USFDA.

Abacavir is one of the non-nucleoside reverse transcriptase inhibitors (NRTIs), a class of drugs that helps prevent AIDS virus from reproducing. It is used in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection. Abacavir is a key component of the ARV regimens in various parts of the world, the company said.

Abacavir Sulphate tablet is the version of Ziagen Tablets, an anti-HIV medication manufactured by GlaxoSmithKline.

The company said its Abacavir would now be available for consideration under the US President's Emergency Plan for AIDS Relief (PEPFAR). Aurobindo Pharma manufactures both active pharmaceutical ingredient (API) and formulation for this generic. With this approval, the ARV product portfolio of the company has increased to 13, the release said.

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