Cephalon Inc (Frazer, PA)
October 3, 2007—Cephalon announced that, beginning in October, Amrix (cyclobenzaprine hydrochloride extended- release capsules) would be available in pharmacies in the United States. Originally approved by the FDA in February 2007, Amrix is the first and only once-daily formulation of the skeletal muscle relaxant cyclobenzaprine hydrochloride. The medication is indicated as an adjunct to rest and physical therapy for the relief of muscle spasm associated with acute, painful musculoskeletal conditions and is intended for short-term use (up to 2 or 3 weeks). Cephalon acquired the North American rights to Amrix from ECR Pharmaceuticals, a privately held company, in August 2007. Amrix provides once-daily dosing. It can be taken in the daytime or at nighttime, but it should be taken at approximately the same time every day.
Extended-release capsules: 15 and 30 mg
Eli Lilly and Co (Indianapolis, IN)
November 30, 2007—Eli Lilly and Co announced that the FDA approved Cymbalta (duloxetine HCl) for the maintenance treatment of major depressive disorder (MDD) in adults. Treating the broad range of depression symptoms (eg, sadness, loss of interest, and fatigue) may minimize the presence of residual symptoms (eg, anxiety, guilt, and low self-esteem) and can help delay the time to relapse. Cymbalta, which belongs to a class of drugs commonly referred to as serotonin and norepinephrine reuptake inhibitors (SNRIs), is already approved for the acute treatment of MDD, the management of diabetic peripheral neuropathic pain, and the treatment of generalized anxiety disorder, all in adults.
Dosage Form: Capsules: 20, 30, and 60 mg
Bayer Pharmaceuticals Corp (West Haven, CT) and Onyx Pharmaceuticals Inc (Emeryville, CA)
November 19, 2007—Bayer HealthCare AG and Onyx Pharmaceuticals Inc announced that the FDA approved a supplemental new drug application for Nexavar (sorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC), or liver cancer. Nexavar, an oral anti-cancer drug, is the first approved systemic drug therapy for liver cancer and the only drug therapy shown to significantly improve overall survival in patients with the disease. Nexavar also is indicated for the treatment of advanced renal cell carcinoma, or advanced kidney cancer. When it received this approval in 2005, Nexavar became the first new treatment in more than a decade for advanced kidney cancer and is currently approved in more than 60 countries for this indication.
Tablets: 200 mg
The Oncology Care Pharmacist in Health-System Pharmacy
According to the National Cancer Institute, almost 40% of men and women will be given a diagnosis of some form of cancer in their lifetime.
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