Pharmacy Times

rx RODUCT news


Aricept (donepezil HCl)

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

Indication: October 13, 2006—Eisai Inc and Pfizer Inc announced that the FDA approved a supplemental new drug application for Aricept for the treatment of severe Alzheimer's disease. With this additional indication, Aricept is now the only prescription medication approved to treat the full spectrum of Alzheimer's disease (mild, moderate, and severe). It has been approved in the United States since 1996 for the treatment of mild-to-moderate Alzheimer's disease.

Dosage Form: Tablets: 5 and 10 mg

For More Information: www.aricept.com 888-999-9616


Coreg CR (carvedilol phosphate)

Marketed by: GlaxoSmithKline (Philadelphia, Pa)

Indication: October 20, 2006—GlaxoSmithKline and Flamel Technologies announced FDA approval of once-a-day Coreg CR extended-release capsules for the treatment of 3 cardiovascular conditions: hypertension; postmyocardial infarction left ventricular dysfunction (cases where a heart attack has reduced how well the heart pumps); and mild-to-severe heart failure. Coreg CR is a third-generation β-blocker, which means that it works by slowing the heart rate and lowering the force with which it pumps. The drug utilizes Flamel's proprietary Micropump technology, which controls the delivery of carvedilol, helping to maintain appropriate amounts of medicine in the body over a 24-hour span.

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

For More Information: www.gsk.com 888-825-5249


Gleevec (imatinib mesylate)

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

Indication: October 19, 2006—Gleevec received US regulatory approval to help patients with 5 distinct and potentially life-threatening disorders, including the solid tumor cancer dermatofibrosarcoma protuberans and 4 blood diseases: (1) relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia; (2) certain forms of myelodysplastic/ myeloproliferative diseases; (3) hypereosinophilic syndrome/ chronic eosinophilic leukemia; and (4) aggressive systemic 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 approved a new indication for the proton pump inhibitor Nexium for the treatment of Zollinger-Ellison syndrome (ZES). It is already indicated for the treatment of gastroesophageal reflux disease in adults and children aged 12 to 17, and to reduce the risk of nonsteroidal anti-inflammatory drug-associated gastric ulcers in at-risk patients. ZES is a rare but serious chronic condition characterized by tumors that 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—AstraZeneca announced FDA approval of Seroquel for the treatment of patients with depressive episodes associated with bipolar disorder. Seroquel was already approved for the treatment of acute manic episodes associated with bipolar I disorder and for the treatment of schizophrenia. It is now the first and only single medication approved by the FDA to treat both depressive and acute manic episodes associated with bipolar disorder.

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 Z 0.004% was approved by the FDA for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of or insufficiently responsive to other intraocular pressure-lowering medications. This new formulation eliminates benzalkonium chloride and replaces it with Sofzia, a robust ionic buffered preservative system that is gentle to the ocular surface.

Dosage Form: 2.5-mL solution in a 4-mL bottle; 5-mL solution in a 7.5-mL bottle

For More Information: www.alconinc.com


Tyzeka (telbivudine)

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

Indication: October 25, 2006—Novartis announced US regulatory approval of Tyzeka as a new once-daily oral treatment taken with or without food for patients with chronic hepatitis B. Tyzeka rapidly and profoundly suppresses the hepatitis B virus in adult patients with evidence of viral replication and either evidence of persistent elevations in serum aminotransferases 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 approved oral Zolinza 400 mg once daily for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CLTL), a form of non- Hodgkin's lymphoma, who have progressive, persistent, or recurrent disease on or following 2 systemic therapies. CLTL is a cancer of the T cells, a type of white 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 Inc announced that the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted unanimously to recommend that adults 60 years and older be vaccinated with Zostavax to help prevent shingles (herpes zoster), a frequently painful disease marked by a blistering rash. Zostavax was approved by the FDA on May 25, 2006, for the prevention of shingles in individuals 60 years and older.

Dosage Form: Package of 1 single-dose vial of lyophilized vaccine and a separate package of 10 vials of diluent; package of 10 single-dose vials of lyophilized vaccine and a separate 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 first and only dipeptidyl peptidase-4 (DPP- 4) inhibitor available in the United States, was approved by the FDA for the treatment of type 2 diabetes. Januvia has been approved as monotherapy and as add-on therapy to either of the 2 other types of oral diabetes medications, metformin or thiazolidinediones, to improve blood sugar control.

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

For More Information: www.merck.com