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.

Date Drug Company
26 June 2008 AZT oral solution (50 mg/5 mL) Cipla, India
19 June 2008 3TC/d4T 30mg/6mg & 60mg/12mg paediatric tablets and oral suspension Cipla, India
25 May 2008 Nevirapine (200mg tabs) Matrix, India

“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 also known as the Orange Book.


This brings the total of FDA approved generic drugs and formulations to 70 since the programme started.

Updated list of generic tentative approvals:

Source: FDA list serve:

An archive of past list serve announcements is available on the FDA web site:

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