FDA clears Aurobindo's abacavir under PEPFAR

The US Food and Drug Administration has tentatively approved a generic version of abacavir sulfate oral solution, 20mg base/mL, manufactured by Aurobindo Pharma of Hyderabad, India.

The drug is the first copy-cat version of the Ziagen Oral Solution brand, manufactured by UK drug major GlaxoSmithKline, which is a formulation indicated for use in HIV patients from three months through 13 years of age. Because of its tentative approval, Aurobindo's drug will now be available for consideration for purchase and use outside the USA under the President's Emergency Plan for AIDS Relief.

The scheme, which President George W Bush first announced in his 2003 State of the Union Address, is currently providing $15.0 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest hit countries. The PEPFAR is designed to prevent seven million new HIV infections, treat at least two million HIV-infected people and care for 10 million HIV-affected individuals, AIDS orphans and vulnerable children, the agency noted.