US FDA approves Glaxo and Gilead drug combinations

6 September 2004. Related: Antiretrovirals.

The US Food and Drug Administration has approved two antiretroviral drug combinations made by GlaxoSmithKline and Gilead Sciences for use in the United States and in developing countries. Truvada, the Gilead medicine, contains emtricitabine and tenofovir. Epzicom, the Glaxo combination, contains lamivudine and abacavir.

The speedy approval time – only four months for Truvada – confirms speculation that US regulations would facilitate rapid approval for brand name drugs so they can be bought with PEPFAR (the $15 billion President’s Emergency Plan for AIDS Relief) dollars in developing countries. Observers are waiting to see if generic drugs are approved as quickly or if, as is expected, they will be held up by the American bureaucracy in order to favour the multinational pharmaceutical companies.

The US price for Truvada is $650.83 and Epzicom is $621.60 for 30-day supplies.

Source: FDA press release
http://www.fda.gov/bbs/topics/news/2004/NEW01099.html

Link (free registration required):
http://www.medscape.com/viewarticle/484763?src=mp