rx PRODUCT news

Published Online: Tuesday, January 1, 2008


Marketed by:
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.

Dosage Form:
Extended-release capsules: 15 and 30 mg

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Marketed by:
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

For More Information:
800-LILLY-RX (800-545-5979)

Hot Rx


Marketed by:
Fleming Pharmaceuticals (St Louis, MO)

November 28, 2007— Fleming Pharmaceuticals today announced the availability of CaloMist (cyanocobalamin, USP), the first and only FDA-approved, once-daily vitamin B12 nasal spray. CaloMist was developed as a maintenance alternative to ongoing B12 intramuscular (IM) injections for patients whose B12 levels have been normalized with IM injections. Vitamin B12 deficiency is more common in the elderly and in adults. Vitamin B12 deficiency is often undetected and can lead to serious neuropsychiatric and hematologic complications, including fatigue, weakness, loss of memory, depression, and anemia.

Dosage Form:
Nasal spray: 25 mcg cyanocobalamin, USP/0.1 mL

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Marketed by:
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.

Dosage Form:
Tablets: 200 mg

For More Information:
866-NEXAVAR (866-639-2827)

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