India-based drug maker Aurobindo Pharma has received tentative approval from the FDA to manufacture and market Abacavir sulfate tablets, which are used in the treatment of HIV infection.
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The new drug application 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 for Abacavir sulfate tablets 300mg and Abacavir sulfate oral solution 20mg/mL.
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