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FDA Approvals - Aurobindo gets US FDA tentative nod for anti-HIV drug (PharmaBiz)


Aurobindo gets US FDA tentative nod for anti-HIV drug (PharmaBiz)
Hyderabad based Aurobindo Pharma Limited has received tentative US FDA approval to manufacture and market fixed dosed combination Abacavir Sulfate/Lamivudine tablets 60/30mg for the treatment of HIV infections.

Aurobindo gets tentative nod for new drug (Business Standard India)
Aurobindo Pharma Limited, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), has received the tentative approval from the US Food and Drug Administration (US FDA) to manufacture and market fixed dosed combination Abacavir Sulfate/Lamivudine tablets in 60mg and 30 mg strengths.

FDA drug approvals rise in 2008, despite complaints over missed review dates (Canadian Business)
The number of new drugs approved by the Food and Drug Administration has ticked upward in 2008, even as regulators failed to meet review deadlines
 

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