Indian company says it has U.S. FDA approval to produce, sell generic AIDS drug
September 20, 2005
By RAJESH MAHAPATRA | Associated Press
NEW DELHI - Major Indian pharmaceutical company Ranbaxy Laboratories Ltd. said Tuesday that its American subsidiary has received U.S. approval to produce and sell a generic version of the drug Retrovir, used for treating infection by HIV.
The patent for Retrovir, made by British pharmaceutical giant GlaxoSmithKline PLC, has just expired, Ranbaxy said in a statement.
The U.S. Food and Drug Administration said on its Web site that Ranbaxy's generic drug zidovudine meets all U.S. safety and efficacy standards, and that it has approved the medication for marketing.
Sales of Retrovir in the United States totaled US$28 million in 2004. The tablets are often used in combination with other drugs to treat HIV infection.
The statement did not indicate how Ranbaxy will price the generic drug, but a company official said on condition of anonymity that it would be "significantly cheaper" than Retrovir.
GlaxoSmithKline officials could not immediately be reached for comment.
Ranbaxy has received tentative FDA approvals for several other generic anti-retroviral drugs, but cannot sell them in the United States because the patents for their branded equivalents have not expired. Final FDA approval for a generic drug is only given only after the branded medicine goes off patent.
But tentative approval means the generic medicines meet FDA standards, and can be used by relief organizations outside the United States that are funded by President George W. Bush's US$15 billion AIDS relief plan.