FDA approval of generic ARVs
1 February 2011. 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 |
|---|---|---|
| 3TC/AZT 30 mg/60 mg dispersible FDC tablets (paediatric) | Matrix, India | 5 January 2011 |
| 3TC/tenofovir 300 mg/300 mg FDC tablets (adults and children >12 years) | Aurobindo, India | 7 January 2011 |
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