FDA approval of generic ARVs
1 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 agencys 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