FDA approval of generic ARVs

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

Drug and formulation Manufacturer, Country Approval date
efavirenz/FTC/tenofovir FDC tablets, 600 mg/200 mg/300 mg Aurobindo, India 2 April 2013

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:

An updated list of generic tentative approvals (now at 140) is available on the FDA website:


FDA list serve

Links to other websites are current at date of posting but not maintained.