Breaking News

March 7, 2005

Crawford nominated to head FDA

Crawford nominated to head FDA Lester Crawford, a veterinarian-pharmacologist, has been nominated to head the FDA. Crawford has served as acting FDA commissioner since last March when Mark McClellan was named to take the helm at CMS. It will be nice to have a permanent FDA head, said NCPA general counsel John Rector, who added that several issues, including regulation of veterinary compounding and MedGuides, would be raised at Crawford's Senate confirmation hearing. NACDS president/CEO Craig Fuller congratulated Crawford and pledged to work with him on community pharmacy and healthcare issues, as well as implementation of President Bush's healthcare agenda

First treatment cleared for HIV and hepatitis C How do you treat the 300,000 Americans coinfected with both HIV and chronic hepatitis C? The FDA has just approved the first and only treatment for adults with these two diseases. It's the use of Pegasys (peginterferon alfa-2a, Roche) in combination with Copegus (ribavirin, USP) 200-mg tablet. Studies have shown that 40% of patients treated with the combination achieved a sustained virological response.

Steroid cream approved for plaque psoriasis Fluocinonide (Vanos, Medicis) cream 0.1%, a class I corticosteroid, has been approved for the treatment of plaque-type psoriasis. The most common adverse effects associated with the use of fluocinonide in clinical trials were headache and burning at the application site. Fluocinonide will be manufactured by Pantheon in Canada and will be available in both a 30-gm and a 60-gm size. The company anticipates launching the product to dermatologists in the second quarter of 2005.

Lunesta proposed for Schedule IV DEA has issued a proposed rule to place eszopiclone (Lunesta, Sepracor) into Schedule IV of the Controlled Substances Act. Written comments must be postmarked, and electronic comments must be sent, on or before March 16. Please reference "Docket No. DEA-262P" on all written and electronic correspondence. Comments may be sent directly to DEA via dea.diversion.policy@usdoj.gov
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Sales of Tysabri suspended Biogen Idec and Elan have voluntarily suspended the marketing and distribution of the multiple sclerosis agent natalizumab (Tysabri). The decision is based on very recent events, which involve one fatal, confirmed case and one suspected case of progressive multifocal leukoencephalopathy. Both patients received more than two years of natalizumab therapy in combination with interferon beta-1a. Physicians are being advised to switch patients on natalizumab to other drugs, and the companies also noted that they are stopping clinical trials of the agent. A copy of the Dear Healthcare Provider letter is available at http://www.tysabri.com/ and the companies' corporate Web sites.