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/d4T 150/30 mg tabs Hetero, India 17 May 2010
abacavir, 300 mg tablets Strides Arcolab, India 12 May 2010
ddI delayed-release capsules, 125 mg, 200 mg, 250 mg, and 400 mg Matrix, India 06 April 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 112 since the programme started. An updated list of generic tentative approvals is available on the FDA website:

Source: FDA list serve: BeyondOurBordersForeignOffices/AsiaandAfrica/ucm119231.htm

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