FDA approval of generic ARVs

Since the last issue of HTB, the US Food and Drug Administration (FDA) has granted full and tentative approval for the following new generic ARV products.

Drug and formulation Manufacturer, Country Approval date
lopinavir/ritonavir oral solution, 80 mg/20 mg/mL Cipla, India 29 June 2012
efavirenz, 600 mg tablets Par Formulations 26 June 2012
efavirenz, 600 mg tablets Edict Pharma, India 25 June 2012
efavirenz, 600 mg tablets Micro Labs, India 20 June 2102
* abacavir 300 mg tablets (full approval) Mylan Pharma 18 June 2012
3TC / AZT FDC scored paediatric tablets for oral suspension tablets, 30 mg /60 mg. For pts 3 months and older & weighing > 5 kg. Cipla, India 15 June 2012
3TC tablets, 150 mg and 300 mg Micro Labs, India 30 May 2012

* full approval; 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.