Business Daily from THE HINDU group of publications
Thursday, Dec 06, 2007
ePaper | Mobile/PDA Version
Business Daily from THE HINDU group of publications Thursday, Dec 06, 2007 ePaper | Mobile/PDA Version |
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Corporate
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Regulatory Bodies & Rulings Matrix Lab gets US FDA nod for AIDS drug Our Bureau Hyderabad, Dec. 5 Matrix Laboratories Ltd has received tentative approval from the US Food and Drug Administration (USFDA) under the President’s Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Tenofovir Disoproxil Fumarate tablets, 300 mg.The Hyderabad-based company’s Tenofovir Disoproxil Fumarate is the first and only generic tentative approval of Gilead Sciences Inc’s Viread tablets. Matrix’s ANDA was tentatively approved in less than six months and is the seventh PEPFAR tentative approval earned by the company within the last 12 months, according to a release. Under PEPFAR, a tentative approval means that a company can immediately sell an HIV/AIDS treatment outside of the US. Although existing patents and/or marketing exclusivity prevent the approval of the product in the US, a tentative approval indicates that the product meets all safety, efficacy and manufacturing quality standards for marketing as per norms in the US. “This helps to ensure AIDS patients abroad who receive these medications get the same quality product as the American public,” the release said.
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