New products: November 19, 2007
New products include brand-name drugs, generics, home-health products, over-the-counter, and health and beauty care.
NEW DRUGS
NEW FORMULATIONS
NEW LABELING
The FDA has approved changes in storage conditions for Humate-P, a protein that helps stop bleeding in certain adult patients with hemophilia A or adult or pediatric patients with von Willebrand disease. Humate-P can now be stored for up to two years at 77o F. The drug is the product of CSL Behring, King of Prussia, Pa., (610) 878-4000.
Sanofi-pasteur, Swiftwater, Pa., (570) 839-7187, is the manufacturer of Menactra, a bacterial meningitis vaccine approved in 2005 for patients ages 11 to 55 years. The vaccine can now be used for children aged two to 10.
Expanded labeling has been approved for Merck & Co.'s Januvia (sitagliptin), initially indicated as an adjunct to diet and exercise for the treatment of Type 2 diabetes. New labeling recommends, in addition to diet and exercise, initial therapy in combination with metformin; add-on therapy to a sulfonylurea when a single agent does not provide adequate glycemic control; and add-on therapy to a sulfonylurea/metformin combination when dual therapy does not provide adequate glycemic control. Also included are postmarketing reports of hypersensitivity reactions that include anaphylaxis, angioedema, and exfoliative skin conditions, including Stevens-Johnson syndrome. Merck is in Whitehouse Station, N.J., at (908) 423-1000.
