Cipla Gets Thumbs Up for Generic HIV Drug
Indian drugmaker Cipla has received FDA approval for its HIV treatment zidovudine oral solution 50 mg/5 mL, a generic version of GlaxoSmithKline’s Retrovir.
The generic Retrovir application was considered under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR), a five-year, $15 billion program aimed at combating HIV and other diseases in 114 countries — including 15 focus countries primarily in Africa — that President Bush announced in 2003.
Zidovudine is a nucleoside reverse transcriptase inhibitor intended to be used with other anti-retroviral agents to treat HIV-1 infection. The approval means no patents or exclusivity prevent marketing the drug in the U.S. The FDA often tentatively approves generic versions of HIV drugs still under patent protection in the U.S. so the generics may be eligible for purchase under PEPFAR for use in other countries, the FDA said.
In February, Matrix Laboratories received FDA approval for its generic version of Retrovir 300-mg tablets.