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
tenofovir/FTC 300 mg/200 mg tablets Hetero Labs, India 22 December 2011
abacavir/3TC 60 mg/30 mg tablet paediatric (> 3 months and >5 kg) Mylan Pharmaceuticals, India 31 January 2012
abacavir/3TC 600 mg/300 mg adult tablet Cipla, India 31 January 2012

FDC: Fixed Dose Combination

‘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 Products with Therapeutic Equivalence Evaluations, also known as the Orange Book:

An updated list of generic tentative approvals (now at 140) is available on the FDA website:

Source: FDA list serve:

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