FDA approval of generic ARVs

HIV Treatment Bulletin - Vol. 8, No. 8/9, August-September 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.

Of these new approvals, the paediatric fixed dose combination of nevirapine/d4T/3TC is by far the most important and innovative, and is the first formulation which takes into account different pharmacokinetic properties of individual drugs necessary for paediatric dosing.

“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 programme 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”

Comment

Of this expanding list, the approval of a paediatric formulation in a Fixed Dose Combination is the most ground-breaking news, and the first formulation of its kind.

This brings the total of FDA approved generic drugs and formulations to 47 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, the lack of protease inhibitors and second-line RTIs, or other drugs that would be effective in treatment-experienced patients, is still alarming.

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

A list of FDA approved generic antiretroviral drugs: http://www.fda.gov/oashi/aids/viralsgeneric.html

2007-08-10
IB070808-30

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