ROCKVILLE, Md., March 31 (UPI) -- The Food and Drug Administration said Friday it has approved generic Retrovir capsules to treat HIV.
The agency said it has cleared for the U.S. market zidovudine in capsule dosage form, the generic version of GlaxoSmithKline's Retrovir, which recently went off patent.
The capsules are made by Hyderabad, India-based Aurobindo Pharma.
The FDA has already approved the anti-retroviral in tablet and oral solution following the September expiration of the patents covering those formulations.
"This is a significant generic approval," said acting FDA Commissioner Andrew von Eschenbach. "Retrovir, which was initially approved in March, 1987, was the first of a group of breakthrough medications that have transformed what was then a disease with a very dismal prognosis into one with a much more hopeful prognosis. Approval of this additional dosage form of zidovudine should help reduce the cost of this therapy for American patients," he said.
Zidovudine belongs to a drug class called nucleoside reverse transcriptase inhibitors, which help stop the AIDS virus from reproducing. It is approved for use in combination with other anti-retrovirals to treat HIV-1 infection, the FDA said.
