Rx Product News: September 2008

Cleviprex

Marketed by:

The Medicines Co (Parsippany, NJ)

Indication:

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

Dosage Form:

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

For More Information:

www.cleviprex.com

Diovan HCT/Exforge

Marketed by:

Novartis AG(Basel, Switzerland)

Indication:

August 4, 2008—The FDAapproved 2 single-pillcombination medications,Diovan HCT (valsartanand hydrochlorothiazide)and Exforge (amlodipineand valsartan), as initialor first-line therapies inpatients likely to needmultiple drugs to achievetheir blood pressuregoals. These approvalswill provide simplified treatment strategies to helpcontrol high blood pressure with Diovan HCT andExforge. In patients who are likely to need multipledrugs to achieve blood pressure goals, using first-linesingle-pill combination medications will help eliminatethe 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 PharmaceuticalsInc (Lincolnshire, IL)

Indication:

August 7, 2008—BioSantePharmaceuticals announcedthat it reacquiredElestrin (estradiol gel) fromNycomed US, which inFebruary 2008 acquired Bradley Pharmaceuticals Inc,BioSante's previous licensee of Elestrin. Elestrin is afast-drying formulation of estradiol, the same estrogenproduced naturally in women, and is approvedby the FDA for the treatment of hot flashes in postmenopausalwomen. Elestrin is absorbed through theskin after topical application on the upper arm, anddelivers estradiol to the bloodstream evenly over timein a nonirritating, painless manner. Elestrin is administeredusing a metered-dose applicator that delivers12.5 mcg of estradiol.

Dosage Form:

Estradiol 0.06% in a colorless, nonstaining hydroalcoholicgel supplied in a nonaerosol, metered-dosepump container

For More Information:www.biosantepharma.com

Evamist

Marketed by:

Ther-Rx Corp(St. Louis, MO)

Indication:

April 1, 2008—Ther-Rx Corp launchedEvamist (estradioltransdermalspray). The productis indicated forthe treatment ofmoderate-to-severevasomotor symptomsdue to menopause.Evamist reduces the frequency and severity ofmoderate-to-severe hot flashes, with sustained deliveryof estrogen. A metered-dose applicator delivers aspray to a small area on the inner forearm and driesquickly. Based on clinical response, the dosage canbe increased to 2 to 3 sprays daily to the forearm.

Dosage Form:

1 spray delivers 90 mcL, which contains 1.53 mgestradiol

For More Information:www.evamist.com877-567-7676

Requip XL

Marketed by:

GlaxoSmithKline(Research TrianglePark, NC)

Indication:

June 13, 2008—GlaxoSmithKlineannounced theapproval of Requip XL (ropinirole extended-releasetablets) by the FDA for the treatment of the signsand symptoms of idiopathic Parkinson's disease. It isthe first and only oral once-daily non-ergot dopamineagonist indicated for Parkinson's disease. Requip XLis an extended-release, once-daily tablet formulationthat uses SkyePharma PLC's patented GEOMATRIXtechnology, which allows for continuous delivery ofropinirole over 24 hours to provide smooth bloodlevels. This extended-release version offers patients asimple titration regimen and a convenient, once-dailydosing schedule.

Dosage Form:

Tablets: 2, 4, and 8 mg

For More Information:www.gsk.com

Stavzor

Marketed by:

NovenPharmaceuticals Inc(Miami, FL)

Indication:

July 30, 2008—NovenPharmaceuticals Incannounced that theFDA approved Stavzor(valproic acid delayedreleasecapsules) in125-, 250-, and 500-mgstrengths. Stavzor isapproved for the treatmentof manic episodesassociated withbipolar disorder, as monotherapy and adjunctive therapyin the treatment of patients with complex partialseizures that occur either in isolation or in associationwith other types of seizures, and for the prophylaxisof migraine headaches. The soft gel capsules aresmall and easy to swallow, with an advanced enterictechnology 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 VaccinesApproved for2008-2009Influenza Season

Vaccines and their Marketers:

Afluria: CSL Biotherapies (King of Prussia, PA);Fluarix and FluLaval: GlaxoSmithKline (ResearchTriangle Park, NC); FluMist: MedImmune VaccinesInc (Gaithersburg, MD); Fluvirin: Novartis Vaccinesand Diagnostics (Cambridge, MA); Fluzone: SanofiPasteur Inc (Swiftwater, PA)

Indication:

August 5, 2008—The FDA approved 6 vaccines forthis year's seasonal influenza vaccines that include3 new strains of the virus likely to cause flu in theUnited States during the 2008-2009 season. A possibilityexists for a suboptimal match between thevirus strains predicted to circulate and the virusstrains that end up causing the most illness. Even ifthe vaccines and the circulating strains are not anexact match, however, they will provide some protectionand may reduce the severity of the illness orprevent 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 Lillyand Co announcedthat the FDA approvedStrattera (atomoxetineHCl) for maintenancetreatment of attention-deficit/hyperactivity disorder(ADHD) in children and adolescents. Strattera is aselective norepinephine reuptake inhibitor and isthe first FDA-approved nonstimulant to treat ADHDin children, adolescents, and adults. In children andadolescents up to 70 kg, the initial daily dose is 0.5mg/kg, with a target daily dose of 1.2 mg/kg and amaximum total daily dose of 1.4 mg/kg. In childrenand adolescents over 70 kg and adults, the initial dailydose is 40 mg, with a target daily dose of 80 mg anda maximum total daily dose of 100 mg.

Dosage Form:

Each capsule contains atomoxetine HCl equivalent to10, 18, 25, 40, 60, 80, or 100 mg of atomoxetine

For More Information:www.strattera.com