FDA Grants Aurobindo Approval for U.S. Sale of Zidovudine Capsule

FDA on Friday granted Indian drug manufacturer Aurobindo Pharma approval to sell and market in the U.S. a capsule dosage of the generic antiretroviral drug zidovudine, Dow Jones reports (Corbett Dooren, Dow Jones, 3/31). The treatment is the first generic capsule form of zidovudine to be approved by FDA for the U.S. market (FDA release, 3/31). FDA approved zidovudine, which belongs to a drug class called nucleoside reverse transcriptase inhibitors, for sale in the U.S. in generic tablet and oral solution form in September 2005 after the expiration of GlaxoSmithKline's patent on the drug, sold under the brand name Retrovir (Kaiser Daily HIV/AIDS Report, 9/21/05). "This is a significant generic approval," Andrew von Eschenbach, acting FDA commissioner, said, adding, "Approval of this additional dosage form of zidovudine should help reduce the cost of this therapy for American patients" (FDA release, 3/31).

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