The US FDA has given the tentative approval for Aurobindo Pharma's zidovudine oral solution, a generic version of a child-friendly oral solution to help keep AIDS virus from reproducing.

Zidovudine is the first tentatively approved generic version of Retrovir brand of the zidovudine oral solution (GlaxoSmithKline). This dosage form of the drug is the first child-friendly oral solution available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).

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. The President's Emergency Plan is designed to prevent seven million new HIV infections, treat at least two million HIV-infected people, and care for ten million HIV-affected individuals, AIDS orphans and vulnerable children.

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 antiretroviral agents for the treatment of HIV-1 infection. This product contains 50 mg/5mL of zidovudine in an oral solution.