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
Atazanavir sulfate capsules, 300 mg Emcur, India 19 August 2010
3TC/d4T FDC 150/30mg Macleods, India 05 August 2010
AZT/3TC/nevirapine tablets for Oral Solution, 60 mg/30 mg/50 mg Matrix Laboratories, India 08 July 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 programme 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 114 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.