USFDA approves Zidovudine tablets
Ranbaxy Laboratories Ltd has received approval from US Food and Drug Administration to manufacture and market Zidovudine tablets.business Updated: Oct 01, 2005 15:19 IST
Ranbaxy Laboratories Ltdsaid on Tuesday thatit has received approval from US Food and Drug Administration to manufacture and market Zidovudine Tablets USP, 300 mg.
The office of Generic Drugs, USFDA, has determined the company's formulations to be bio-equivalent and have the same therapeutic effect as that of the reference listed drug Retrovir USP, 300 mg by GalxoSmithkline, the company informed the Bombay Stock Exchange.
Zidovudine tablets in combination with other anti-retroviral agents are indicated for the treatment of HIV infection, it said.
"Generic ARVs are essential for winning the worldwide struggle against HIV/AIDs, an epidemic now infecting approximately 40 million people around the globe. We are also working with the US Federal Government and non-government organizations to provide ARVs to patients afflicted with this disease who might not have access to such medications outside of the US, " said Brian Tempest, CEO and Managing Director, Ranbaxy.