FDA Grants Tentative Approval to First Generic for Antiretroviral Viread
The U.S. Food and Drug Administration has issued a tentative approval for a generic version of Viread (tenofovir disoproxil fumarate), a drug for use in combination with other antiretroviral agents in the treatment of HIV.
Tentative approval means that although existing patents and/or marketing exclusivity prevent the approval of the product in the United States at this time, the product meets all of FDA’s manufacturing quality and clinical safety and efficacy requirements.
The action marks the first tentative approval for a nucleotide analog reverse transcriptase inhibitor (nRTI). The nRTIs block an enzyme called reverse transcriptase, which is important to HIV production.
“The fight to save lives with high-quality anti-retroviral treatment is of significant importance to FDA,” said Gary Buehler, director of FDA’s Office of Generic Drugs. “Our scientists have been working diligently to make safe and effective treatments for AIDS available as quickly as possible to combat this worldwide problem.”
Tenofovir disoproxil fumarate is the latest addition of an anti-retroviral product that can be considered for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR), a five-year, $15 billion effort to fight the HIV/AIDS pandemic — the largest commitment ever by a single nation toward an international health initiative.
All FDA reviews of applications received in association with the PEPFAR program are expedited. FDA reviewed this application for generic tenofovir disoproxil fumarate tablets in less than six months.
The U.S. Department of Health and Human Services and its agencies, including FDA, are part of an interagency effort under PEPFAR to accomplish the President’s goals of treating 2 million HIV-infected people, preventing 7 million new infections, and caring for 10 million people infected with and affected by HIV/AIDS, including orphans and vulnerable children.
As of Sept. 30, 2007, PEPFAR supported life-saving anti-retroviral treatment for a total of more than 1.3 million men, women and children in 15 focus countries in sub-Saharan Africa, Asia and the Caribbean. On May 30, 2007, President Bush announced that he would work with Congress to reauthorize PEPFAR for another five years.
The tenofovir disoproxil fumarate 300 milligram tablets are manufactured by Matrix Laboratories, LTD, of Andhra Pradesh, India.
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FDA Generic Drugs
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