rx PRODUCT news

Pharmacy Times, Volume 0,0

Amrix

Marketed by:

Cephalon Inc(Frazer, PA)

Indication:

October 3, 2007—Cephalonannounced that, beginning inOctober, Amrix (cyclobenzaprinehydrochloride extended-release capsules) would be available in pharmaciesin the United States. Originally approved by the FDA inFebruary 2007, Amrix is the first and only once-dailyformulation of the skeletal muscle relaxant cyclobenzaprinehydrochloride. The medication is indicated asan adjunct to rest and physical therapy for the relief ofmuscle spasm associated with acute, painful musculoskeletalconditions and is intended for short-termuse (up to 2 or 3 weeks). Cephalon acquired the NorthAmerican rights to Amrix from ECR Pharmaceuticals, aprivately held company, in August 2007. Amrix providesonce-daily dosing. It can be taken in the daytimeor at nighttime, but it should be taken at approximatelythe same time every day.

Dosage Form:

Extended-release capsules: 15 and 30 mg

For More Information:

www.amrix.com

800-896-5855

Cymbalta

Marketed by:

Eli Lilly and Co(Indianapolis, IN)

Indication:

November 30, 2007—Eli Lillyand Co announced that theFDA approved Cymbalta (duloxetineHCl) for the maintenancetreatment of major depressivedisorder (MDD) in adults. Treating the broad range ofdepression symptoms (eg, sadness, loss of interest,and fatigue) may minimize the presence of residualsymptoms (eg, anxiety, guilt, and low self-esteem) andcan help delay the time to relapse. Cymbalta, whichbelongs to a class of drugs commonly referred to asserotonin and norepinephrine reuptake inhibitors(SNRIs), is already approved for the acute treatment ofMDD, the management of diabetic peripheral neuropathicpain, and the treatment of generalized anxietydisorder, all in adults.

Dosage Form:Capsules: 20, 30, and 60 mg

For More Information:

www.cymbalta.com

800-LILLY-RX (800-545-5979)

Hot Rx

CaloMist

Marketed by:

Fleming Pharmaceuticals(St Louis, MO)

Indication:

November 28, 2007—Fleming Pharmaceuticalstoday announced theavailability of CaloMist(cyanocobalamin, USP), thefirst and only FDA-approved,once-daily vitamin B12 nasal spray. CaloMist wasdeveloped as a maintenance alternative to ongoingB12 intramuscular (IM) injections for patients whoseB12 levels have been normalized with IM injections.Vitamin B12 deficiency is more common in the elderlyand in adults. Vitamin B12 deficiency is often undetectedand can lead to serious neuropsychiatric andhematologic complications, including fatigue, weakness,loss of memory, depression, and anemia.

Dosage Form:

Nasal spray: 25 mcg cyanocobalamin, USP/0.1 mL

For More Information:

www.flemingpharma.com

800-343-9497

Nexavar

Marketed by:

Bayer PharmaceuticalsCorp (West Haven, CT) andOnyx Pharmaceuticals Inc(Emeryville, CA)

Indication:

November 19, 2007—BayerHealthCare AG and Onyx Pharmaceuticals Inc announcedthat the FDA approved a supplemental newdrug application for Nexavar (sorafenib) tablets for thetreatment of patients with unresectable hepatocellularcarcinoma (HCC), or liver cancer. Nexavar, an oral anti-cancerdrug, is the first approved systemic drug therapyfor liver cancer and the only drug therapy shown tosignificantly improve overall survival in patients withthe disease. Nexavar also is indicated for the treatmentof advanced renal cell carcinoma, or advancedkidney cancer. When it received this approval in 2005,Nexavar became the first new treatment in more thana decade for advanced kidney cancer and is currentlyapproved in more than 60 countries for this indication.

Dosage Form:

Tablets: 200 mg

For More Information:

www.nexavar.com

866-NEXAVAR (866-639-2827)