FDA approval of generic ARVs
29 May 2013. Related: Treatment access.
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 |
|---|---|---|
| efavirenz/FTC/tenofovir FDC tablets, 600 mg/200 mg/300 mg | Aurobindo, India | 2 April 2013 |
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 (now at 140) 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