HTB South

FDA approval of generic ARVs

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

Drug and formulation Manufacturer, Country Approval date
AZT/3TC tablets, 300 mg/150 mg Teva, USA ** 25 May 2011
Tenofovir DF tablets, 300 mg Strides, India 25 May 2011
Abacavir/3TC scored tablets, 60 mg/30 mg Cipla, India 12 May 2011

** Full approval enables this generic to be sold in the US.

FDC: Fixed Dose Combination

Effective patent dates are listed in the agency’s publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book:
http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm

An updated list of generic tentative approvals is available on the FDA website:
http://www.fda.gov/oia/pepfar.htm

Source:

FDA list serve:
http://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/AsiaandAfrica/ucm119231.htm

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