FDA approval of generic ARVs
1 October 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 for pediatric patients 3 months and older weighing at least 5 kg. | Cipla, India | 22 September 2011 |
| 3TC/tenofovir 300 mg/300 mg FDC tablets co-package with nevirapine 200mg tablets | Matric laboratories, India | 8 September 2011 |
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
Global Fund adopts restructuring recommendations and close to 50% funding shortfall for next round of grants