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Abilify


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

Indication:
November 20, 2007—The FDA approved a supplemental new drug application for the atypical antipsychotic Abilify (aripiprazole) as adjunctive, or add-on, treatment to antidepressant therapy in adults with major depressive disorder (MDD). Abilify is the first medication approved by the FDA as add-on treatment for MDD. Abilify also is indicated for the treatment of schizophrenia in adolescents aged 13 to 17 years. The FDA first approved Abilify on November 15, 2002, for the treatment of schizophrenia in adults. 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, 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—The FDA approved the supplemental new drug application for the antihypertensive agent Avalide (irbesartan-hydrochlorothiazide) for initial use in patients with hypertension who are likely to need multiple drugs to achieve their blood pressure goals. Avalide tablets are a combination of an angiotensin II receptor antagonist, Avapro (irbesartan), and a thiazide diuretic, hydrochlorothiazide. Avalide is the first combination therapy to be indicated by the FDA for first-line use in patients with moderate-to-severe hypertension. It also was the first combination therapy 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 receptor blocker, has been approved following a priority review by the FDA for the treatment of high blood pressure in children and adolescents aged 6 to 16. Thirty percent of American adults are currently living with high blood pressure, and new reports estimate that nearly 5% of children 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 clinically stable patients with left ventricular failure or left ventricular 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 the FDA approved a supplemental new drug application for Januvia (sitagliptin), the only DPP-4 inhibitor available in the United States for the treatment of type 2 diabetes. Januvia is already indicated, as an adjunct to diet and exercise, to improve glycemic control in adult patients with type 2 diabetes. Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. It has not been studied in combination with insulin. The new regimens with Januvia described in the updated labeling include: for use in combination with metformin as an adjunct to diet and exercise as initial therapy to improve glycemic control; as add-on therapy to a sulfonylurea (glimepiride) when the single agent alone does not provide adequate glycemic control; and as add-on therapy to the combination of a sulfonylurea (glimepiride) and metformin when dual therapy 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—Forest Laboratories Inc and Mylan Inc announced FDA approval of the novel beta blocker Bystolic (nebivolol). Bystolic is indicated for the treatment of hypertension. It is a once-daily medication that can be used alone or in combination with other antihypertensive agents. Hypertension affects roughly 72 million individuals in the United States, and 65% of patients diagnosed with hypertension have not reduced their blood pressure to a satisfactory range (blood pressure <140/90 mm Hg). In an extensive clinical trial program involving more than 2000 patients, Bystolic demonstrated significant reductions in sitting diastolic and systolic blood pressure in a general hypertensive population. Like other beta blockers, Bystolic decreases heart rate and myocardial contractility and suppresses renin activity; it has the added pharmacologic properties of producing vasodilation and reducing total peripheral resistance. Forest licensed US and Canadian rights to Bystolic from Mylan Inc in January 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—Sciele Pharma Inc announced that the FDA approved all 4 dosage strengths of the new Sular (nisoldipine) formulation. The new Sular formulation uses SkyePharma's patented Geomatrix technology and provides a lower dose of Sular for each of its current doses. Sular is an extended-release tablet dosage form of the dihydropyridine calcium channel blocker nisoldipine for oral use. It is indicated for the treatment of hypertension and may be used alone or in combination with other antihypertensive agents. The company expects to launch the new Sular formulation during 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—BioMarin Pharmaceutical Inc announced that the FDA granted marketing approval for Kuvan (sapropterin dihydrochloride) tablets, the first specific drug therapy approved for the treatment of phenylketonuria (PKU). Kuvan is indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia due to tetrahydrobiopterin-responsive PKU and is to be used in conjunction with a Phe-restricted diet. To determine if the patient responds to Kuvan, the recommended starting dose of Kuvan is 10 mg/kg/day taken once daily for up to a month. If the patient does not respond, the drug dose may be increased to 20 mg/kg/day for up to a month. The dose may be adjusted within a range of 5 to 20 mg/kg/day in patients 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—Wyeth Pharmaceuticals, a division of Wyeth, announced that the FDA approved Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension, a new addition to the Protonix family of prescription medications. Protonix For Delayed- Release Oral Suspension can be administered orally in applesauce or apple juice, or through a nasogastric tube. Protonix For Delayed-Release Oral Suspension is indicated for the treatment and maintenance of healing of erosive esophagitis with associated gastroesophageal reflux disease symptoms.

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

For More Information:
www.wyeth.com