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Aurobindo Pharma gets US FDA approval for Abacavir sulfate tabs
Our Bureau, Mumbai | Wednesday, September 17, 2008, 08:00 Hrs  [IST]

Aurobindo Pharma Limited has received the tentative approval to manufacture and market Abacavir sulfate tablets 60mg from the US Food & Drug Administration (US FDA).

The New Drug Application (NDA) 22-293 provides for the use of Abacavir sulfate 60mg tablets in combination with other antiretrovirals for use in paediatric patients for the treatment of HIV-1 infection.

The company had earlier received tentative approvals to Abacavir sulfate tablets 300mg and Abacavir sulfate oral solution 20mg/mL.

This is Aurobindo's 77th ANDA approval from US FDA.

Aurobindo Pharma, headquartered at Hyderabad, manufactures generic pharmaceuticals and active pharmaceutical ingredients.

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