Aurobindo Pharma gets US FDA nod for Abacavir Sulfate tablets

Mumbai, May 23 (UNI) Aurobindo Pharma has been granted tentative approval from the US Food and Drug Administration (FDA) for Abacavir Sulfate - 300 mg (base) tablets.

Announcing this, the company said this is the first generic version approval given by US FDA and the product will now be available for consideration, for purchase under the PEPFAR. It manufactures both API and formulation for this generic.

With this approval, the 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.

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 agents for the treatment of HIV-1 infection. Abacavir sulfate tablet is the version of Ziagen tablets, an anti-HIV medication manufactured by GlaxoSmithKline.

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