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: