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 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:
An updated list of generic tentative approvals is available on the FDA website: