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
24 November 2009 Efavirenz tablets 50, 100 and 200 mg tablets Matrix, India
20 November 2009 Lopinavir/ritonavir tablets 200/50mg Cipla, India
5 November 2009 3TC/tenofovir DF 300/300mg Fixed Dose Combination (FDC) Heteo, 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 104 since the programme started.

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

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