July 18, 2006
Product news from the 07/18/06 News Brief
The FDA approved Bristol-Myers Squibb’s and Gilead Sciences’ Atripla, the first ever once-a-day single tablet regimen to treat HIV as a stand-alone therapy or in combination with other retrovirals. It is the first AIDS treatment to mix drugs made by different manufacturers. Atripla combines Bristol-Myers Squibb’s Sustiva, and Gilead’s Truvada.The two companies established their joint venture to develop and commercialize Atripla in December 2004. The FDA cleared Atripla in less than three months as part of a push to introduce treatments that combine already-approved HIV drugs. Eli Lilly’s Gemzar (gemcitabine HCl) has won approval by the FDA for use in the expanded indication of the treatment of women living with recurrent ovarian cancer. Valeant Pharmaceuticals has launched Zelapar (selegiline HCl) orally disintegrating tablets -- the first Parkinson's disease treatment to use a novel oral delivery system called Zydis Technology, which allows the tablets to dissolve within seconds in the mouth and deliver more active drug at a lower dose.