Aurobindo drug gets FDA nod

Aurobindo Pharma Ltd has announced that the US FDA has granted tentative approval for abacavir sulfate tablets 300 mg (base). This is the first generic version approval given by US FDA to the company.

The aforesaid product will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR). Aurobindo manufactures both active pharmaceutical ingredients (APIs) and formulations for this generic.

With this approval, the anti-retro viral (ARV) product portfolio of the company has increased to 13. Abacavir is a key component of the ARV regimens in various parts of the world and 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 ARV agents for the treatment of HIV-1 infection. Abacavir sulfate tablet is the version of Ziagen tablets, an anti-HIV medication manufactured by GlaxoSmithKline.