Ranbaxy gets FDA tentative approval for zidovudine generic

Domestic pharma major Ranbaxy Laboratories (RL) has received the tentative approval for zidovudine tablets from the US Food and Drug Administration (US FDA).

The product contains 300 mg of zidovudine in each tablet, and is the first generic version of the already-approved product manufactured by GlaxoSmithKline called as Retrovir. Because of the tentative approval by FDA, this Ranbaxy generic product will now be available for consideration for purchase and use outside the United States under the President’s Emergency Plan for AIDS Relief, a release from US FDA.

Zidovudine is in the class of drugs called nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing. This anti-retroviral drug is intended to be used with other anti-retroviral agents for the treatment of HIV-1 infection.

The Emergency Plan for AIDS Relief, which President Bush first announced in his 2003 State of the Union Address, is currently providing $15 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest-hit countries.