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
Tenofovir DF, 300mg tabs Hetero, India 06 April 2010
Nevirapine tablets for oral suspension, 50 mg, for children weighing >5 kg Aurobindo, India 24 February 2010
Efavirenz cross-scored tablets, 200 mg (to be broken into two 100 mg or four 50 mg doses for paediatric dosing. Strides Arcolab, India 12 February 2010

“Tentative Approval” means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but because of existing patents and/or exclusivity rights, it cannot yet be marketed in the United States. Tentative approval does, however make the product eligible for consideration for purchase under the PEPFAR program for use outside the United States.

Effective patent dates are listed in the agency’s publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book:


This brings the total of FDA approved generic drugs and formulations to 108 since the programme

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

Source: FDA list serve:


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