[Ip-health] FDA approves Aspen's fixed-dose combination generic ARV

[Mike Palmedo]

http://business.iafrica.com/news/406200.htm

Aspen spikes with FDA approval

iafrica.com
25 Jan 2005

Pharmaceutical group Aspen Pharmacare's share price jumped 3.68 percent
or 70 cents to 19.70 rand per share on Tuesday, on the news that the
company had received US Food and Drug Administration approval, for use
of certain of its generic antiretrovirals (ARVs).

Aspen CEO Stephen Saad said the landmark approval confirmed Aspen as the
first pharmaceutical manufacturer in the world, to successfully receive
approval for Generic Antiretrovirals by the US FDA via the expedited
review process.

The approval is for the co-packed and most widely used triple cocktail
combination of Lamivudine/Zidovudine and Nevirapine tablets in
conventional adult dosages.

The FDA registration also means that Aspen has become the first
accredited generic supplier to have access to the US President's
Emergency Plan for Aids Relief (PEPFAR) fund.

This is a fund of $15-billion that has been designated by President
George Bush for developing countries.

"It is understood that upwards of 50 to 60 percent of these funds will
be used to purchase ARVs and other HIV/Aids related pharmaceuticals from
accredited suppliers.

Aspen will sell this co-packaged combination to bona fide recipients of
PEPFAR at affordable prices," Aspen CEO Stephen Saad said on Tuesday.