rx PRODUCT news

Pharmacy Times, Volume 0, 0

Abilify

Marketed by:

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

Indication:

November 20, 2007—The FDAapproved a supplemental new drugapplication for the atypical antipsychoticAbilify (aripiprazole) as adjunctive,or add-on, treatment to antidepressanttherapy in adults with major depressivedisorder (MDD). Abilify is the first medication approvedby the FDA as add-on treatment for MDD. Abilify alsois indicated for the treatment of schizophrenia in adolescentsaged 13 to 17 years. The FDA first approvedAbilify on November 15, 2002, for the treatment ofschizophrenia in adults. It also is indicated for thetreatment of acute manic or mixed episodes associatedwith bipolar I disorder in adults. Abilify injection isindicated for the treatment of adults with agitationassociated with schizophrenia or bipolar I disorder,manic or mixed.

Dosage Form:

Tablets: 2, 5, 10, 15, 20, and 30 mg; Abilify DiscmeltOrally Disintegrating Tablets: 10 and 15 mg; 1 mg/mLnonrefrigerated oral solution; and single-dose, ready-to-use solution for intramuscular injection 7.5 mg/mL

For More Information:

www.abilify.com

Avalide

Marketed by:

sanofi-aventis and Bristol-Myers Squibb Co (Paris, France, and Princeton, NJ)

Indication:

November 20, 2007—TheFDA approved the supplementalnew drug application for the antihypertensiveagent Avalide (irbesartan-hydrochlorothiazide) for initialuse in patients with hypertension who are likely toneed multiple drugs to achieve their blood pressuregoals. Avalide tablets are a combination of anangiotensin II receptor antagonist, Avapro (irbesartan),and a thiazide diuretic, hydrochlorothiazide. Avalide isthe first combination therapy to be indicated by theFDA for first-line use in patients with moderate-to-severehypertension. It also was the first combinationtherapy approved by the FDA in 1997.

Dosage Form:Tablets: 150/12.5, 300/12.5, and 300/25 mg

For More Information:

www.AVAPROAVALIDE.com

Diovan

Marketed by:

Novartis Pharmaceuticals Corp(East Hanover, NJ)

Indication:

December 3, 2007—Diovan (valsartan),an angiotensin receptorblocker, has been approved followinga priority review by theFDA for the treatment of high blood pressure in childrenand adolescents aged 6 to 16. Thirty percent ofAmerican adults are currently living with high bloodpressure, and new reports estimate that nearly 5% ofchildren and adolescents may have this condition.Diovan also is indicated for the treatment of hypertension,the treatment of heart failure (NYHA class II-IV),and the reduction of cardiovascular mortality in clinicallystable patients with left ventricular failure or leftventricular dysfunction following myocardial infarction.

Dosage Form:Tablets: 40, 80, 160, and 320 mg

For More Information:

www.novartis.com

Januvia

Marketed by:

Merck & Co Inc(Whitehouse Station, NJ)

Indication:

October 17, 2007—Merck &Co Inc announced that theFDA approved a supplementalnew drug application forJanuvia (sitagliptin), the onlyDPP-4 inhibitor available in the United States for thetreatment of type 2 diabetes. Januvia is already indicated,as an adjunct to diet and exercise, to improveglycemic control in adult patients with type 2 diabetes.Januvia should not be used in patients withtype 1 diabetes or for the treatment of diabeticketoacidosis. It has not been studied in combinationwith insulin. The new regimens with Januvia describedin the updated labeling include: for use in combinationwith metformin as an adjunct to diet and exercise asinitial therapy to improve glycemic control; as add-ontherapy to a sulfonylurea (glimepiride) when the singleagent alone does not provide adequate glycemic control;and as add-on therapy to the combination of asulfonylurea (glimepiride) and metformin when dualtherapy does not provide adequate glycemic control.

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

For More Information:

www.merck.com

Hot Rx

Bystolic

Marketed by:

Forest Laboratories Inc(New York, NY)

Indication:

December 18, 2007&#8212;ForestLaboratories Inc and Mylan Incannounced FDA approval of the novelbeta blocker Bystolic (nebivolol).Bystolic is indicated for the treatment of hypertension.It is a once-daily medication that can be usedalone or in combination with other antihypertensiveagents. Hypertension affects roughly 72 million individualsin the United States, and 65% of patientsdiagnosed with hypertension have not reduced theirblood pressure to a satisfactory range (blood pressure<140/90 mm Hg). In an extensive clinical trialprogram involving more than 2000 patients, Bystolicdemonstrated significant reductions in sitting diastolicand systolic blood pressure in a general hypertensivepopulation. Like other beta blockers, Bystolicdecreases heart rate and myocardial contractilityand suppresses renin activity; it has the added pharmacologicproperties of producing vasodilation andreducing total peripheral resistance. Forest licensedUS and Canadian rights to Bystolic from Mylan Inc inJanuary 2006.

Dosage Form:

Tablets: 2.5, 5, and 10 mg

For More Information:

www.bystolic.com

800-678-1605

Sular

Marketed by:

Sciele Pharma Inc(Atlanta, GA)

Indication:

January 2, 2008&#8212;Sciele Pharma Inc announced thatthe FDA approved all 4 dosage strengths of the newSular (nisoldipine) formulation. The new Sular formulationuses SkyePharma's patented Geomatrix technologyand provides a lower dose of Sular for each of itscurrent doses. Sular is an extended-release tabletdosage form of the dihydropyridine calcium channelblocker nisoldipine for oral use. It is indicated for thetreatment of hypertension and may be used alone orin combination with other antihypertensive agents.The company expects to launch the new Sular formulationduring the first quarter of 2008.

Dosage Form:

Tablets: 10, 20, 30, and 40 mg

For More Information:

www.sciele.com

800-461-3696

Kuvan

Marketed by:

BioMarin Pharmaceutical Inc(Novato, CA)

Indication:

December 13, 2007&#8212;BioMarinPharmaceutical Inc announcedthat the FDA granted marketingapproval for Kuvan (sapropterindihydrochloride) tablets, the first specific drug therapyapproved for the treatment of phenylketonuria (PKU).Kuvan is indicated to reduce blood phenylalanine(Phe) levels in patients with hyperphenylalaninemiadue to tetrahydrobiopterin-responsive PKU and is tobe used in conjunction with a Phe-restricted diet. Todetermine if the patient responds to Kuvan, the recommendedstarting dose of Kuvan is 10 mg/kg/daytaken once daily for up to a month. If the patient doesnot respond, the drug dose may be increased to 20mg/kg/day for up to a month. The dose may beadjusted within a range of 5 to 20 mg/kg/day inpatients who respond to Kuvan.

Dosage Form:Tablets: 100 mg

For More Information:

www.Kuvan.com

877-MY-KUVAN (877-695-8826)

Protonix

Marketed by:

Wyeth Pharmaceuticals(Collegeville, PA)

Indication:

November 15, 2007&#8212;Wyeth Pharmaceuticals, a divisionof Wyeth, announced that the FDA approvedProtonix (pantoprazole sodium) For Delayed-ReleaseOral Suspension, a new addition to the Protonix familyof prescription medications. Protonix For Delayed-Release Oral Suspension can be administered orally inapplesauce or apple juice, or through a nasogastrictube. Protonix For Delayed-Release Oral Suspension isindicated for the treatment and maintenance of healingof erosive esophagitis with associated gastroesophagealreflux disease symptoms.

Dosage Form:Pantoprazole sodium enteric-coated granules in a 40-mg unit-dose packet

For More Information:

www.wyeth.com