Generic For Antiretroviral Viread Gets FDA Tentative Approval

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Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 19 Dec 2007 - 0:00 PDT

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As part of the President's Emergency Plan for AIDS Relief, the FDA (Food and Drug Administration) has granted a tentative approval for a generic version of antiretroviral tenofovir disoproxil fumarate (Viread). Tenofovir disoproxil fumarate is used as a combination treatment of HIV - it is used along with other antiretroviral agents.

What is Tentative Approval?

It means that although the drug still enjoys existing patents and/or marketing exclusivity, it meets all the FDA's manufacturing quality and clinical safety and efficacy requirements. In this case, it is the first tentative approval for an nRTI (nucleotide analog reverse transcriptase inhibitor) - a drug that blocks transcriptase, an enzyme which is vital for HIV production.

Gary Buehler, Director, Office of Generic Drugs, FDA, says "The fight to save lives with high-quality anti-retroviral treatment is of significant importance to FDA. Our scientists have been working diligently to make safe and effective treatments for AIDS available as quickly as possible to combat this worldwide problem."

PEPFAR (the President's Emergency Plan for AIDS Relief) is a 5-year $15 billion endeavor to combat HIV/AIDS globally - it is the largest single commitment to fighting global HIV/AIDS. Tenofovir disoproxil fumarate is the latest addition of an anti-retroviral product to this effort.

All FDA reviews of applications which are linked to PEPFAR are dealt with swiftly. This case, of generic tenofovir disoproxil fumarate tablets, took under six months to review.

The tenofovir disoproxil fumarate 300 milligram tablets are produced by Matrix Laboratories, LTD, Andhra Pradesh, India.

www.pepfar.gov
www.fda.gov/oia/pepfar.htm

Written by - Christian Nordqvist


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