FDA approval of generic ARVs
15 August 2011. Related: Treatment access.
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:
An updated list of generic tentative approvals is available on the FDA website: