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TREATMENT ACCESS

FDA approval of generic ARVs

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

Date	Drug	Company
29 January 2008	3TC (300 & 150 mg)	Hetero, India

“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
http://www.fda.gov/cder/ob/default.htm

comment

This brings the total of FDA approved generic drugs and formulations to 52 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

Whilst generic approval has led to a wide range of NNRTI-based options for first-line therapy, including in paediatric formulations, there is a clear lack of protease inhibitors and second-line RTIs, or other drugs that would be effective in treatment experienced patients.

Source:

FDA list serve
http://www.fda.gov/oashi/aids/listserve/archive.html

An archive of past list serve announcements is available on the FDA web site
http://www.fda.gov/oashi/aids/listserve/archive.html

A list of FDA approved generic antiretroviral drugs for the treatment of HIV is available
http://www.fda.gov/oashi/aids/viralsgeneric.html

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