Aurobindo Pharma Ltd has been granted by US FDA the tentative approval for the zidovudine 300 mg tablets.
This approval by US FDA makes the company to qualify under the President's Emergency Plan for AIDS Relief (PEPFAR) program for the above tablet, said a company release.
US FDA already granted tentative approval to a generic combination drug product manufactured by the company consisting of Lamivudine 150 mg and Zidovudine 300 mg.
Since zidovudine is going off patent this month, this tentative approval may lead to final approval, that will allow the company to sell the same in the US Market, the release adds.
Zidovudine is a nucleoside reverse transcriptase inhibitor (NRTIs), intended to be used with other antiretroviral agents for the treatment of HIV-1 infection.