FDA OKS NEW GENERIC HIV DRUG FOR OVERSEAS MARKETING

Pharmacy Times, Volume 0, 0

The FDA has granted tentativeapproval for generic abacavirsulfate tablets—the firstgeneric version of Glaxo-SmithKline's Ziagen anti-HIVmedication. The generic productwill be manufactured byAurobindo Pharma Ltd ofHyderabad, India, and will beavailable for consideration forpurchase under the President'sEmergency Plan for AIDS Relief.

The FDA's tentative approvalof this product means thatAurobindo's product meets allof the FDA's manufacturingquality and clinical safety andefficacy standards. Althoughexisting patents preclude marketingthe new generic in theUnited States, the drug can besold abroad and used underthe President's plan.