HTB South

FDA approval of generic ARVs

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

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