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Pharmacy Times
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Aricept (donepezil HCl)

Marketed by:Eisai Inc (Teaneck, NJ) and Pfizer Inc(New York, NY)

Indication:October 13, 2006—Eisai Inc andPfizer Inc announced that the FDAapproved a supplemental new drugapplication for Aricept for the treatment of severeAlzheimer's disease. With this additional indication,Aricept is now the only prescription medicationapproved to treat the full spectrum of Alzheimer's disease(mild, moderate, and severe). It has beenapproved in the United States since 1996 for thetreatment of mild-to-moderate Alzheimer's disease.

Dosage Form:Tablets: 5 and 10 mg

For More Information:www.aricept.com888-999-9616

Coreg CR (carvedilol phosphate)

Marketed by:GlaxoSmithKline(Philadelphia, Pa)

Indication:October 20, 2006—GlaxoSmithKline and FlamelTechnologies announced FDA approval of once-a-dayCoreg CR extended-release capsules for the treatmentof 3 cardiovascular conditions: hypertension;postmyocardial infarction left ventricular dysfunction(cases where a heart attack has reduced how well theheart pumps); and mild-to-severe heart failure. CoregCR is a third-generation β-blocker, which means that itworks by slowing the heart rate and lowering theforce with which it pumps. The drug utilizes Flamel'sproprietary Micropump technology, which controls thedelivery of carvedilol, helping to maintain appropriateamounts of medicine in the body over a 24-hour span.

Dosage Form:Capsules: 10, 20, 40, and 80 mg

For More Information:www.gsk.com888-825-5249

Gleevec (imatinib mesylate)

Marketed by:Novartis Pharmaceuticals Corp(East Hanover, NJ)

Indication:October 19, 2006—Gleevec receivedUS regulatory approval to help patients with 5 distinctand potentially life-threatening disorders, including thesolid tumor cancer dermatofibrosarcoma protuberansand 4 blood diseases: (1) relapsed/refractoryPhiladelphia chromosome-positive acute lymphoblasticleukemia; (2) certain forms of myelodysplastic/myeloproliferative diseases; (3) hypereosinophilic syndrome/chronic eosinophilic leukemia; and (4) aggressivesystemic mastocytosis.

Dosage Form:Tablets: 100 and 400 mg

For More Information:www.novartis.com

Nexium (esomeprazole magnesium)

Marketed by:AstraZeneca (Wilmington, Del)

Indication:October 12, 2006—The FDA approveda new indication for the proton pumpinhibitor Nexium for the treatment ofZollinger-Ellison syndrome (ZES). It is already indicatedfor the treatment of gastroesophageal reflux diseasein adults and children aged 12 to 17, and to reducethe risk of nonsteroidal anti-inflammatory drug-associatedgastric ulcers in at-risk patients. ZES is a rarebut serious chronic condition characterized by tumorsthat secrete excess levels of gastrin.

Dosage Form:Delayed-release capsules: 20 and 40 mg

For More Information:www.nexium-us.com

Seroquel (quetiapine fumarate)

Marketed by:AstraZeneca (Wilmington, Del)

Indication:October 20, 2006—AstraZenecaannounced FDA approval of Seroquelfor the treatment of patients withdepressive episodes associated withbipolar disorder. Seroquel was already approved forthe treatment of acute manic episodes associatedwith bipolar I disorder and for the treatment of schizophrenia.It is now the first and only single medicationapproved by the FDA to treat both depressiveand acute manic episodes associated with bipolardisorder.

Dosage Form:Tablets: 25, 50, 100, 200, 300, and 400 mg

For More Information:www.seroquel.com

Travatan Z (travoprost ophthalmic solution)

Marketed by:Alcon Inc(Fort Worth, Tex)

Indication:September 21, 2006—Travatan Z0.004% was approved by theFDA for the reduction of elevated intraocular pressurein patients with open-angle glaucoma or ocular hypertensionwho are intolerant of or insufficiently responsiveto other intraocular pressure-lowering medications.This new formulation eliminates benzalkoniumchloride and replaces it with Sofzia, a robust ionicbuffered preservative system that is gentle to the ocularsurface.

Dosage Form:2.5-mL solution in a 4-mL bottle; 5-mL solution in a7.5-mL bottle

For More Information:www.alconinc.com

Tyzeka (telbivudine)

Marketed by:Novartis Pharmaceuticals Corp(East Hanover, NJ) and IdenixPharmaceuticals(Cambridge, Mass)

Indication:October 25, 2006—Novartisannounced US regulatory approval of Tyzeka as a newonce-daily oral treatment taken with or without foodfor patients with chronic hepatitis B. Tyzeka rapidlyand profoundly suppresses the hepatitis B virus inadult patients with evidence of viral replication andeither evidence of persistent elevations in serumaminotransferases or histologically active disease.

Dosage Form:Tablets: 600 mg

For More Information:www.novartis.com

Zolinza (vorinostat)

Marketed by:Merck & Co Inc(Whitehouse Station, NJ)

Indication:October 6, 2006—The FDA approvedoral Zolinza 400 mg once daily for thetreatment of cutaneous manifestationsin patients with cutaneous T-celllymphoma (CLTL), a form of non-Hodgkin's lymphoma, who have progressive, persistent,or recurrent disease on or following 2 systemictherapies. CLTL is a cancer of the T cells, a type ofwhite blood cell, which affects the skin.

Dosage Form:Capsules: 100 mg

For More Information:www.merck.com

Zostavax (zoster vaccine live [Oka/Merck])

Marketed by:Merck & Co Inc(Whitehouse Station, NJ)

Indication:October 25, 2006—Merck & Co Incannounced that the US Centers forDisease Control and Prevention'sAdvisory Committee on ImmunizationPractices voted unanimously to recommend thatadults 60 years and older be vaccinated withZostavax to help prevent shingles (herpes zoster), afrequently painful disease marked by a blisteringrash. Zostavax was approved by the FDA on May 25,2006, for the prevention of shingles in individuals 60years and older.

Dosage Form:Package of 1 single-dose vial of lyophilized vaccineand a separate package of 10 vials of diluent; packageof 10 single-dose vials of lyophilized vaccine and aseparate package of 10 vials of diluent

For More Information:www.merck.com

Januvia (sitagliptan phosphate)

Marketed by:Merck & Co Inc(Whitehouse Station, NJ)

Indication:October 17, 2006—Januvia, the firstand only dipeptidyl peptidase-4 (DPP-4) inhibitor available in the United States, wasapproved by the FDA for the treatment of type 2 diabetes.Januvia has been approved as monotherapy andas add-on therapy to either of the 2 other types of oraldiabetes medications, metformin or thiazolidinediones,to improve blood sugar control.

Dosage Form:Tablets: 25, 50, and 100 mg

For More Information:www.merck.com

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