FDA Approval of Generic ARVs
Since the last issue of HTB, the U.S. Food and Drug Administration (FDA) has granted full and tentative approval for the following new generic ARV products.
Fixed Dose Combinations are reviewed for PEPFAR under the FDA guidance titled "Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV."
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 (now at 140) is available on the FDA website.
Source: FDA list serve.
Links to other websites are current at date of posting but not maintained.
This article was provided by HIV i-Base. It is a part of the publication HIV Treatment Bulletin. Visit HIV i-Base's website to find out more about their activities, publications and services.
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