Indian Generic Drug Company Cipla Receives FDA Approval For U.S. Sale Of Antiretroviral Zidovudine

Main Category: HIV / AIDS
Also Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals
Article Date: 03 Jul 2008 - 6:00 PST

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Indian generic pharmaceutical company Cipla recently received full FDA approval to sell and market in the U.S. an oral generic version of the antiretroviral drug zidovudine, the Drug Industry Daily reports. Cipla's application for zidovudine was considered under the expedited review provisions of the President's Emergency Plan for AIDS Relief (Drug Industry Daily, 6/30).

According to an FDA release, zidovudine belongs to a drug class called nucleoside reverse transcriptase inhibitors, which helps keep HIV from replicating. The drug is intended to be used in combination with other antiretrovirals. FDA has approved other forms of zidovudine in the U.S. after GlaxoSmithKline's patent on the drug -- sold under the brand name Retrovir -- expired. The approval means that there are no existing patents or exclusivity preventing the approval of generic versions of the drug for marketing and sale in the U.S. (FDA release, 6/27).

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