Important note: Information in this article was accurate in June 2006. The state of the art may have changed since the publication date.
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HIV Treatment Bulletin - Vol. 7, No. 6, June 2006
On 18 May 2006, the Food and Drug Administration (FDA) granted tentative approval for a generic version of abacavir, manufactured by Aurobindo Pharma LTD. of Hyderabad, India.
This is the first FDA approval for a generic version of abacavir. Tentative approval makes this product available for consideration for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR).
The agency’s tentative approval means that Aurobindo’s product meets all of FDA’s manufacturing quality and clinical safety and efficacy standards, but existing patents and/or exclusivity prevent its marketing in the United States at this time.
The list of approved drugs tracked in HTB over the last year is shown in Table 1.
Table 1: FDA tentative approvals of generic ARVs
Source for Table 1: individual FDA list serve posts
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This is the first generic formulation of abacavir to be approved by the FDA and is an essential addition to the list of generic drugs that can now be used by the PEPFAR programme.
Although the FDA approval process has approved at least 15 ARV formulations since the programme was first announced in May 2004, it is difficult to know how many PEPFAR programmes have switched to these equivalent but less expensive formulations.
Anecdotally, activists report that programmes in Kenya, Tanzania and Zambia still use Brand drugs, but there currently seems no centralised report of any switch to these new formulations.
2006-06-10
IB060706-25
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