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FDA Approval of Generic ARVs

July/August 2011

Since the last issue of HTB, the U.S. Food and Drug Administration (FDA) has granted tentative approval (or full approval*) for the following new generic ARV products.


Drug and formulation Manufacturer, Country Approval date
AZT/3TC tablets, 300 mg/150 mg Teva, USA* 25 May 2011
Tenofovir DF tablets, 300 mg Strides, India 25 May 2011
Abacavir/3TC scored tablets, 60 mg/30 mg Cipla, India 12 May 2011


FDC: Fixed-Dose Combination

Effective patent dates are listed in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book:
www.accessdata.fda.gov/scripts/cder/ob/default.cfm

An updated list of generic tentative approvals is available on the FDA website:
www.fda.gov/oia/pepfar.htm

Source:

FDA list serve:
www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/AsiaandAfrica/ucm119231.htm

* Full approval enables this generic to be sold in the U.S.

Links to external websites are current at time of posting but not maintained.

 


  
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This article was provided by HIV i-Base. It is a part of the publication HIV Treatment Bulletin. Visit HIV i-Base's website to find out more about their activities, publications and services.
 
See Also
More on the FDA Drug Approval Process and Other Regulatory Issues

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