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
3TC/AZT 30 mg/60 mg dispersible FDC tablets (paediatric) Matrix, India 5 January 2011
3TC/tenofovir 300 mg/300 mg FDC tablets (adults and children >12 years) Aurobindo, India 7 January 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:

An updated list of generic tentative approvals is available on the FDA website:


FDA list serve:

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