Aurobindo Pharma, a Hyderabad-based manufacturer of generic pharmaceuticals and active pharmaceutical ingredients (APIs), has received the tentative approval from the US Food and Drug Administration (USFDA) to manufacture and market abacavir sulfate tablets in 60 mg strength. This is the company’s 77th abbreviated new drug application (ANDA) approval from the USFDA.
The 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 for abacavir sulfate tablets 300 mg and oral solution 20 mg/ml, Aurobindo stated in a press release on Wednesday.
