FDA Announces First Time Tentative Approval Of Indian Anti-AIDS Drugs

The US Food and Drug Administration (FDA) has for the first time given its tentative approval to two anti-HIV/AIDS drugs made by Indian pharmaceutical companies, in a major policy shift that would enable millions of HIV-infected patients buy cheaper drugs. The FDA has announced the tentative approval of two applications for nevirapine tablets manufactured by Ranbaxy Laboratories Limited, Guragon, India and Aurobindo Pharma Limited, Hyderabad, India, the agency said in a statement yesterday. The tentative approval means that although existing patents and exclusivity prevent the marketing of Aurobindo's and Ranbaxy's products in the US, these products meet all of FDA's quality, safety and efficacy standards required for marketing in the US. As such, they are now eligible to be considered for purchase and use outside the US.