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.