List of current FDA approved generic formulations and products

HIV Treat Bull - Vol. 7, No. 7/8, July/August 2006

In June 2006, the Food and Drug Administration (FDA) granted tentative approval for the following Indian generic products:

The list of approved drugs tracked in HTB over the last year is shown in Table 1.

This brings the total of FDA approved generic drugs and formulations to over 20 since the programme was launched.

Athough the tentative approval process was developed so that more patients should be treated with less expensive formulations in PEPFAR programmes, it is unclear whether these US rogrammes are universally switching to the generic drugs.

An updated list of generic tentative approvals is included as a table in the article below. This will be updated as new approvals are announced and is accessible at:

http://www.i-base.info/itpc/fdageneric.html

While generic approval and competition have produced a side range of NNRTI-based options for first-line therapy, protease inhibitors and second-line RTIs, or other drugs effective for treatment experienced patients, are clearly missing from this list.

Table 1: FDA tentative approvals of generic ARVs
View table

Source for Table: FDA list serve

2008-03-10
IB060707-24

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