Mumbai: Aurobindo Pharma today said it has received the US administration’s approval to manufacture and market the drug used for treatment of HIV infections.
The company has received the tentative approval from US Food and Drug Administration (USFDA) for Efavirenz tablets in 100 mg, Aurobindo Pharma said in a filing to the Bombay Stock Exchange.
The new drug application provides for the use of Efavirenz tablets in combination with other antiretrovirals agents and is indicated for the treatment of HIV infections, it added.
The company had earlier received tentative approvals to Efavirenz tablets 600 mg, Efavirenz capsules 50, 100 and 200 mg and co-packaged Lamivudine or Zidovudine tablets and Efavirenz tablets 150 mg, 300 mg and 600 mg, the filing added.
Further, this is Aurobindo’s 86 ANDA approval from USFDA, it said.