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
d4T/3TC/nevirapine FDC tablets 30 mg/150 mg/200 mg Hetero, India 10 September 2010
d4T/3TC/nevirapine FDC
tablets 30 mg/150 mg/200 mg
Macleods, India 30 August 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.

Fixed Dose Combinations are reviewed for PEPFAR under the FDA guidance titled “Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously approved Antiretrovirals for the Treatment of HIV”. This document was developed to clarify what regulatory requirements apply to such applications, what issues might be of concern, and how these issues should be addressed. The guidance is intended to encourage sponsors to submit applications for combination and co-packaged products, and to facilitate submission of such applications to FDA.

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


This brings the total of FDA approved generic drugs and formulations to 116 since the programme started. 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.