The drug is the first generic version of Ziagen Tablets, an anti-HIV medication already approved by the FDA.
Aurobindo Pharma LTD. of Hyderabad, India manufactures the generic version, which will now be available for consideration of purchase under the President's Emergency Plan for AIDS Relief.
Murray M. Lumpkin, M.D., Deputy Commissioner for International and Special Programs, says in a statement, "FDA's action adds yet another anti-HIV product to those available for purchase under the President's Plan and demonstrates our continuing commitment to ensuring that safe, effective, and quality manufactured medications are available for purchase under the President's Plan."
President Bush introducted the President's Emergency Plan for AIDS Relief in his 2003 State of the Union Address. It provides $15 billion to fight HIV/AIDS over five years, and focuses on 15 of the hardest hit countries.
Abacavir is one of the non-nucleoside reverse transcriptase inhibitors, a class of drugs that helps keep the AIDS virus from reproducing. It is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.
The agency's tentative approval of this product means that Aurobindo's product meets all of the FDA's manufacturing quality and clinical safety and efficacy standards. However, existing patents and/or exclusivity prevent its marketing in the United States.
