It was a busy week on the Hill, with hearings on the tobacco legislation, among other things and the FDA budget is getting a lot of attention (see below).
- FDA Takes Action to Halt Marketing of Unapproved Ergotamine Companies Ordered to Cease Manufacturing and Distribution of Illegal Drugs to Treat Migraine Headaches – How’s that for a headline? Sort of says it all, doesn’t it? The agency told 20 companies to cease marketing unapproved drug products containing ergotamine tartrate, used to treat vascular headaches, including migraines.
- FDA Approves New Treatment For Crohn’s Disease – The agency announced approval of Humira (adalimumab) to treat adult patients with moderately to severely active Crohn’s disease. According to the release, "Humira was previously approved for the treatment of three autoimmune diseases: rheumatoid arthritis, a chronic inflammation of the joints; psoriatic arthritis, which causes joint swelling and scaly skin; and ankylosing spondylitis, a systemic rheumatic disease that affects the spine and sacroiliac joints. Humira is manufactured by Abbott Laboratories, Abbott Park, Ill."
- FDA Clears Baxter’s Modified Infusion Pump – Not only approved, but the agency used the company’s name in the press release headline – kudos to someone. According to the agency, they "cleared for marketing a modified Colleague Volumetric Infusion Pump which addresses many of the problems that prompted a series of Class I recalls and a product seizure in 2005."
- Galvus Gets Approvable Letter – Novartis received an approvable letter for Galvus, a member of a new class of diabetes treatments. The agency is seeking more study on how the drug affects patients with kidney impairment.
- FDA Approves First Drug To Prevent and Treat Vomiting in Dogs – For those of us who often travel with our pups, relief for some is in sight. Fortunately Nick and Nora do not have this problem, but for those that do, the agency announced this week the approval of two formulations of Cerenia (maropitant citrate), a new class of drug that is effective against certain causes of vomiting in dogs. Cerenia Tablets are indicated for the prevention of acute vomiting and vomiting due to motion sickness, and Cerenia Injectable Solution is approved for the prevention and treatment of acute vomiting. The drug has been approved by the EMEA and you can see information on it. It is the second canine approval this year.
- Cha Ching – FDA Budget Web Page – I came across a newly designed Web page on the FDA site that has budgets for this FY 2008 and going back to FY 2005. It wasn’t rocket science, the link was right there on the home page, but I had not noticed it until now. But I thought it might be a handy tool for those interested in comparing. In addition, there is a little explanation on how the FDA budget is prepared.
It was another week on the road for me, folks. Hope you had a good week and enjoy a special weekend.