/publications/issue/2008/2008-06/2008-06-8581

rx PRODUCT news

Author:

Cimzia

Marketed by:

UCB Inc (Smyrna, GA)

Indication:
April 22, 2008?UCB announced that the FDA has approved Cimzia (certolizumab pegol), the first and only pegylated anti-tumor necrosis factor-alpha (TNFa) antibody. Cimzia is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate-to-severe active disease who have an inadequate response to conventional therapy. Cimzia has a high affinity for human TNFa, selectively neutralizing the pathophysiologic effects of TNFa. TNFa plays a key role in mediating pathologic inflammation, and excess TNFa production has been directly implicated in a wide variety of diseases.

Dosage Form:
200 mg lyophilized powder for reconstitution with 1 mL of sterile water for injection, USP

For More Information:
www.ucb-group.com



Fenoglide

Marketed by:

Sciele Pharma Inc and LifeCycle Pharma Inc (Atlanta, GA)

Indication:
February 21, 2008?Sciele Pharma Inc and LifeCycle Pharma Inc announced that Sciele has launched Fenoglide in the United States. Fenoglide is indicat ed for the treatment of hyperlipidemia and hypertrig-lyceridemia. The product uses LifeCycle Pharma's Meltdose technology, a clinically validated reformulation technology, which is designed to provide enhanced absorption and greater bioavailability. Fenoglide will be the lowest dose of fenofibrate available for patients

Dosage Form:
Tablets: 40 and 120 mg

For More Information:
800-849-9707
www.sciele.com



Luvox CR

Marketed by:

Jazz Pharmaceuticals Inc (Palo Alto, Ca)

Indication:
February 28, 2008?Jazz Pharmaceuticals Inc announced that the FDA has approved once-a-day Luvox CR (fluvoxamine maleate) extended-release capsules for the treatment of social anxiety disorder (SAD) and obsessive compulsive disorder (OCD) in adults. SAD, also known as social phobia, as defined in the Diagnostic and Statistical Manual of Mental Disorders-IV, is characterized by a marked and persistent fear of one or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. The obsessions or compulsions involved with OCD cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. Luvox CR is a selective serotonin reuptake inhibitor that incorporates Elan's SODAS (Spheroidal Oral Drug Absorption System) technology designed to minimize peak-to-trough plasma level fluctuations over a 24-hour period.

Dosage Form:
Capsules: 100 and 150 mg

For More Information:
www.JazzPharmaceuticals.com



Omnaris

Marketed by:

Sepracor Inc (Marlborough, MA)

Indication:
April 17, 2008?Sepracor Inc announced that Omnaris (ciclesonide) Nasal Spray is available by prescription in pharmacies nationwide. Omnaris Nasal Spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children aged 6 years and older and with perennial allergic rhinitis in adults and adolescents aged 12 and older. The spray contains the active ingredient ciclesonide, a corticosteroid that is activated into desciclesonide after administration. It has potent anti-inflammatory activity and a high affinity for glucocorticoid receptors.

Dosage Form:
Nasal spray: 50 mcg (recommended dose is 200 mcg/day administered as 2 sprays [50 mcg/spray] in each nostril once daily)

For More Information:
www.omnaris.com



Patanase

Marketed by:

Alcon Inc (Huenenberg, Switzerland)

Indication:
April 15, 2008?Alcon Inc announced that the FDA has approved Patanase (olopatadine hydrochloride) nasal spray, an H1 receptor antagonist, for the relief of symptoms of seasonal allergic rhinitis in patients aged 12 years and older. Patanase is intended only for intranasal administration. The recommended dosage is 2 sprays per nostril twice daily.

Dosage Form:
Nasal spray 0.6%: 665 mcg of olopatadine hydrochloride in each 100-?L spray; supplied in a 30.5-g bottle containing 240 sprays

For More Information:
www.alcon.com



Relistor

Marketed by:
Wyeth Pharmaceuticals, a division of Wyeth (Collegeville, PA)

Developed with:
Progenics Pharmaceuticals Inc (Tarrytown, NY)

Indication:
April 25, 2008?Progenics and Wyeth Pharmaceuticals announced that the FDA has approved Relistor (methylnaltrexone bromide) subcutaneous injection, a peripherally acting mu-opioid receptor antagonist for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. The recommended dose is 8 mg for patients weighing 38 to <62 kg (84 to <136 lb) or 12 mg for patients weighing 62 to 114 kg (136 to 251 lb). Patients weighing outside of those ranges should be dosed at 0.15 mg/kg. Relistor is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

Dosage Form:
12-mg/0.6-mL solution for subcutaneous injection in a single-use vial

For More Information:
www.relistor.com



Treximet

Marketed by:

GlaxoSmithKline (Philadelphia, PA) and Pozen Inc (Chapel Hill, NC)

Indication:
April 15, 2008?GlaxoSmithKline and Pozen Inc announced that the FDA has approved Treximet (sumatriptan and naproxen sodium) for the acute treatment of migraine attacks with or without aura in adults. Treximet should be used only where a clear diagnosis of migraine headache has been established. Treximet is the first and only migraine product designed to target multiple mechanisms of migraine by combining a triptan and an anti-inflammatory pain reliever in a single tablet.

Dosage Form:
Tablets: 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium

For More Information:
www.gsk.com
www.pozen.com



Simcor

Marketed by:

Abbott Laboratories (Abbott Park, IL)

Indication:
February 15, 2008?Abbott received FDA approval for Simcor, the first fixed-dose combination of 2 widely prescribed cholesterol therapies?Niaspan (Abbott's proprietary niacin extended-release) and simvastatin. Simcor is approved for use along with diet to reduce levels of elevated total cholesterol, low-density lipoprotein cholesterol, and triglycerides, or to raise high-density lipoprotein cholesterol in patients with primary hypercholesterolemia or mixed dyslipidemia when treatment with simvastatin or niacin extended-release monotherapies are not considered adequate.

Dosage Form:
Tablets: 500, 750, and 1000 mg

For More Information:
800-633-9110
www.rxabbott.com/pdf/simcor_pi.pdf