Pharmacy Times

rx PRODUCT news


Combigan

Marketed by:
Allergan Inc (Irvine, Calif)

Indication:
October 31, 2007—Allergan Inc announced that the FDA approved Combigan (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, an alpha-adrenergic receptor agonist with a beta-adrenergic receptor inhibitor, for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. Combigan ophthalmic solution provides a dual mechanism of action to lower IOP by reducing production of aqueous humor, the fluid in the eye that fills the space between the cornea and the iris, and enhancing aqueous humor drainage via the uveoscleral pathway.

Dosage form:
Solution containing 2 mg/mL brimonidine tartrate and 5 mg/mL timolol

For more information:
www.combigan.com



Crestor

Marketed by:
AstraZeneca (Wilmington, Del)

Indication:
November 9, 2007— AstraZeneca announced that the FDA approved Crestor (rosuvastatin calcium) as an adjunct to diet to slow the progression of atherosclerosis (the progressive buildup of plaque in the inner walls of the arteries) in patients with elevated cholesterol. The condition is a silent disease, with no visible signs or symptoms. Crestor also is indicated as adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, ApoB, non-highdensity lipoprotein (HDL) cholesterol, and triglycerides and to increase HDL in adult patients with primary hyperlipidemia or mixed dyslipidemia.

Dosage form:
Tablets: 5, 10, 20, and 40 mg

For more information:
www.crestor.com Isentress



Isentress

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

Indication:
October 12, 2007—Merck & Co Inc announced the FDA granted accelerated approval of Isentress (raltegavir) tablets for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents. Isentress is the first medicine to be approved in a new class of antiretroviral drugs called integrase inhibitors. Isentress works by inhibiting the insertion of HIV DNA into human DNA by the integrase enzyme. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells.

Dosage form:
Tablets: 400 mg

For more information:
www.isentress.com



Lamisil Oral Granules

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

Indication:
October 5, 2007—Novartis Pharmaceuticals Corp announced that the FDA approved Lamisil (terbinafine hydrochloride) Oral Granules for the treatment of tinea capitis (ringworm of the scalp) in patients 4 years of age and older. The condition affects between 3 million and 4 million people in the United States, most of whom are children younger than 10 years of age. Lamisil Oral Granules work when the active ingredient terbinafine treats the infected scalp area, allowing the scalp to heal over a period of time. The treatment regimen for tinea capitis with Lamisil Oral Granules is once a day for 6 weeks. The granules are supplied in packets that contain film-coated granules that should be sprinkled on a teaspoon of food and swallowed.

Dosage form:
125- and 187.5-mg packets containing film-coated granules

For more information:
www.lamisil.com



Lexiva

Marketed by:
GlaxoSmithKline (Research Triangle Park, NC)

Indication:
October 12, 2007—The FDA approved the administration of GlaxoSmithKline's HIV protease inhibitor Lexiva (fosamprenavir calcium) with 100 mg of ritonavir, an agent that increases the level of protease inhibitors in the bloodstream. The FDA approved once-daily Lexiva 1400 mg with 100 mg of ritonavir in adult patients who had not previously taken a protease inhibitor. Lexiva is indicated in combination with other antiretrovirals for the treatment of HIV infections. Ritonavir works with Lexiva and other protease inhibitors to boost the medication levels in the bloodstream, making the protease inhibitor more effective in suppressing HIV. HIV medicines do not cure HIV infections/AIDS or prevent transmission of HIV to others.

Dosage form:
Tablets: 700 mg Oral suspension: 50 mg/mL

For more information:
www.lexiva.com



Menactra

Marketed by:
Sanofi Pasteur Inc (Swiftwater, Pa)

Indication:
October 19, 2007— Sanofi Pasteur Inc, the vaccines division of sanofi-aventis Group, announced that the FDA granted licensure to expand the indication for its meningococcal conjugate vaccine, Menactra (meningococcal [groups A, C, Y, and W-135] polysaccharide diphtheria toxoid conjugate vaccine), to include children aged 2 to 10 years of age. Menactra was originally approved by the FDA in January 2005 for individuals aged 11 to 55 years. Meningitis is a serious inflammation of the lining that surrounds the spinal cord and brain and can result in death or permanent injury to the brain and nervous system. Menactra vaccine offers protection against 4 of the 5 most common serogroups of the bacterium that cause meningococcal infection, Neisseria meningitides serogroups A, C, Y, and W-135.

Dosage form:
Single 0.5-mL injection by intramuscular route

For more information:
www.sanofipasteur.us 800-VACCINE (800-822-2463)


HOT Rx—Abilify

Marketed by:
Otsuka Pharmaceutical Co Ltd (Tokyo, Japan) and Bristol-Myers Squibb Co (Princeton, NJ)

Indication:
November 6, 2007—Otsuka Pharmaceutical Co Ltd and Bristol- Myers Squibb Co announced that the FDA approved the atypical antipsychotic Abilify (aripiprazole) for the treatment of schizophrenia in adolescents aged 13 to 17 years. Abilify treats positive and negative symptoms of schizophrenia in adolescents. The FDA first approved Abilify on November 15, 2002, for the treatment of schizophrenia in adults. Abilify is the first and only available dopamine partial agonist. It also is indicated for the treatment of acute manic or mixed episodes associated with bipolar I disorder in adults. Abilify injection is indicated for the treatment of adults with agitation associated with schizophrenia or bipolar I disorder, manic or mixed.

Dosage form:
Tablets: 2, 5, 10, 15, 20, and 30 mg; Abilify Discmelt Orally Disintegrating Tablets: 10 and 15 mg; 1 mg/mL nonrefrigerated oral solution; and single-dose, readyto- use solution for intramuscular injection 7.5 mg/mL

For more information:
www.abilify.com


Voltaren Gel 1%

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

Indication:
October 22, 2007—Voltaren Gel (diclofenac sodium topical gel) 1% received US regulatory approval as the first topical prescription treatment that patients can apply directly to sites of pain associated with osteoarthritis. The FDA approved Voltaren Gel, which is a nonsteroidal anti-inflammatory medication, for use in treating pain associated with osteoarthritis in joints amenable to topical treatment, such as the knees and the hands. Osteoarthritis is a chronic condition characterized by the breakdown of cartilage in the joint.

Dosage form:
1% gel

For more information:
www.voltarengel.com 800-452-0051