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
