FDA approval of generic ARVs

HIV Treatment Bulletin - Vol. 8, No. 11&12, November/December 2007

Since the last issue of HTB, the US Food and Drug Administration (FDA) has granted tentative approval for the following new generic ARV products.

“Tentative Approval” means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but because of existing patents and/or exclusivity rights, it cannot yet be marketed in the United States. Tentative approval does, however make the product eligible for consideration for purchase under the PEPFAR program for use outside the United States.

Effective patent dates are listed in the agency’s publication titled,

Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the “Orange Book"

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Of this expanding list, this is the first approval of tenofovir, which will enable both more tolerable first-line and more effective second-line options. This brings the total of FDA approved generic drugs and formulations to 51 since the programme started.

An updated list of generic tentative approvals is included as a table on the i-Base website: http://www.i-base.info/itpc/fdageneric.html

Source: FDA list serve

A list of FDA approved generic antiretroviral drugs for the treatment of HIV is available on the web atOpen link in new window http://www.fda.gov/oashi/aids/viralsgeneric.html

2008-11-01
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