FDA announced the tentative approval of zidovudine oral solution, a generic version of a child-friendly oral solution to help keep AIDS virus from reproducing.
Zidovudine, manufactured by Aurobindo Pharma LTD. Hyderabad, India, is the first tentatively approved generic version of Retrovir brand of the zidovudine oral solution (manufactured by 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).
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.