FDA approval of generic ARVs
1 November 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:
An updated list of generic tentative approvals is available on the FDA website:
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