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Aurobindo Pharma gets approval for Abacavir Sulfate tabs
Aurobindo Pharma Limited is pleased to announce that it has received the tentative approval to manufacture and market Abacavir Sulfate tablets 60mg from the US Food & Drug Administration
Aurobindo Pharma Limited is pleased to announce that it has received the tentative approval to manufacture and market Abacavir Sulfate tablets 60mg from the US Food & Drug Administration (USFDA).
The New Drug Application (NDA) 22-293 provides for the use of Abacavir Sulfate 60mg Tablets in combination with other antiretrovirals for use in pediatric 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 USFDA.