Rx Product News

Published Online: Monday, September 1, 2008

Cleviprex

Marketed by:

The Medicines Co (Parsippany, NJ)

Indication:

August 4, 2008—The Medicines Co announced that the FDA approved the intravenous therapy Cleviprex (clevidipine butyrate) injectable emulsion for the reduction of blood pressure when oral therapy is not feasible or not desirable. A novel antihypertensive, Cleviprex represents advancement over currently available therapies, providing rapid and precise control of blood pressure in the critical care setting.

Dosage Form:

Single-use vials: 50 or 100 mL. Concentration is 0.5 mg/mL.

For More Information:
www.cleviprex.com



Diovan HCT/Exforge

Marketed by:

Novartis AG (Basel, Switzerland)

Indication:

August 4, 2008—The FDA approved 2 single-pill combination medications, Diovan HCT (valsartan and hydrochlorothiazide) and Exforge (amlodipine and valsartan), as initial or first-line therapies in patients likely to need multiple drugs to achieve their blood pressure goals. These approvals will provide simplified treatment strategies to help control high blood pressure with Diovan HCT and Exforge. In patients who are likely to need multiple drugs to achieve blood pressure goals, using first-line single-pill combination medications will help eliminate the added steps of starting on a single medication, increasing the dose, and then adding another medication.

Dosage Form:

Diovan HCT tablets (valsartan/hydrochlorothiazide): 80/12.5, 160/12.5, 160/25, 320/12.5, 320/25 mg; Exforge tablets (amlodipine/valsartan): 5/160, 10/160, 5/320, 10/320 mg

For More Information:
www.entegrion.com



Elestrin

Marketed by:

BioSante Pharmaceuticals Inc (Lincolnshire, IL)

Indication:

August 7, 2008—BioSante Pharmaceuticals announced that it reacquired Elestrin (estradiol gel) from Nycomed US, which in February 2008 acquired Bradley Pharmaceuticals Inc, BioSante's previous licensee of Elestrin. Elestrin is a fast-drying formulation of estradiol, the same estrogen produced naturally in women, and is approved by the FDA for the treatment of hot flashes in postmenopausal women. Elestrin is absorbed through the skin after topical application on the upper arm, and delivers estradiol to the bloodstream evenly over time in a nonirritating, painless manner. Elestrin is administered using a metered-dose applicator that delivers 12.5 mcg of estradiol.

Dosage Form:

Estradiol 0.06% in a colorless, nonstaining hydroalcoholic gel supplied in a nonaerosol, metered-dose pump container

For More Information:
www.biosantepharma.com



Evamist

Marketed by:

Ther-Rx Corp (St. Louis, MO)

Indication:

April 1, 2008—Ther-Rx Corp launched Evamist (estradiol transdermal spray). The product is indicated for the treatment of moderate-to-severe vasomotor symptoms due to menopause. Evamist reduces the frequency and severity of moderate-to-severe hot flashes, with sustained delivery of estrogen. A metered-dose applicator delivers a spray to a small area on the inner forearm and dries quickly. Based on clinical response, the dosage can be increased to 2 to 3 sprays daily to the forearm.

Dosage Form:

1 spray delivers 90 mcL, which contains 1.53 mg estradiol

For More Information:
www.evamist.com
877-567-7676



Requip XL

Marketed by:

GlaxoSmithKline (Research Triangle Park, NC)

Indication:

June 13, 2008— GlaxoSmithKline announced the approval of Requip XL (ropinirole extended-release tablets) by the FDA for the treatment of the signs and symptoms of idiopathic Parkinson's disease. It is the first and only oral once-daily non-ergot dopamine agonist indicated for Parkinson's disease. Requip XL is an extended-release, once-daily tablet formulation that uses SkyePharma PLC's patented GEOMATRIX technology, which allows for continuous delivery of ropinirole over 24 hours to provide smooth blood levels. This extended-release version offers patients a simple titration regimen and a convenient, once-daily dosing schedule.

Dosage Form:

Tablets: 2, 4, and 8 mg

For More Information:
www.gsk.com



Stavzor

Marketed by:

Noven Pharmaceuticals Inc (Miami, FL)

Indication:

July 30, 2008—Noven Pharmaceuticals Inc announced that the FDA approved Stavzor (valproic acid delayedrelease capsules) in 125-, 250-, and 500-mg strengths. Stavzor is approved for the treatment of manic episodes associated with bipolar disorder, as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures, and for the prophylaxis of migraine headaches. The soft gel capsules are small and easy to swallow, with an advanced enteric technology designed to reduce reflux and gastric irritability.

Dosage Form:

Capsules: 125, 250, and 500 mg

For More Information:
www.stavzor.com


Hot OTC

6 Flu Vaccines Approved for 2008-2009 Influenza Season

Vaccines and their Marketers:

Afluria: CSL Biotherapies (King of Prussia, PA); Fluarix and FluLaval: GlaxoSmithKline (Research Triangle Park, NC); FluMist: MedImmune Vaccines Inc (Gaithersburg, MD); Fluvirin: Novartis Vaccines and Diagnostics (Cambridge, MA); Fluzone: Sanofi Pasteur Inc (Swiftwater, PA)

Indication:

August 5, 2008—The FDA approved 6 vaccines for this year's seasonal influenza vaccines that include 3 new strains of the virus likely to cause flu in the United States during the 2008-2009 season. A possibility exists for a suboptimal match between the virus strains predicted to circulate and the virus strains that end up causing the most illness. Even if the vaccines and the circulating strains are not an exact match, however, they will provide some protection and may reduce the severity of the illness or prevent flu-related complications.

For More Information:
www.fda.gov/cber/flu/flu2008.htm



Strattera

Marketed by:

Eli Lilly and Co (Indianapolis, IN)

Indication:

May 8, 2008—Eli Lilly and Co announced that the FDA approved Strattera (atomoxetine HCl) for maintenance treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. Strattera is a selective norepinephine reuptake inhibitor and is the first FDA-approved nonstimulant to treat ADHD in children, adolescents, and adults. In children and adolescents up to 70 kg, the initial daily dose is 0.5 mg/kg, with a target daily dose of 1.2 mg/kg and a maximum total daily dose of 1.4 mg/kg. In children and adolescents over 70 kg and adults, the initial daily dose is 40 mg, with a target daily dose of 80 mg and a maximum total daily dose of 100 mg.

Dosage Form:

Each capsule contains atomoxetine HCl equivalent to 10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine

For More Information:
www.strattera.com


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