Rx Product News

Author:

HOT Rx


Victoza

Marketed by:
Novo Nordisk Inc (Princeton, NJ)

Indication:
The FDA recently approved the new drug application for Victoza (liraglutide [rDNA origin] injection), the first and only once-daily human glucagon-like peptide-1 (GLP-1) analog, with 97% homology to natural GLP-1, for the treatment of type 2 diabetes. Victoza is indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Victoza can be used alone (monotherapy) as well as in combination with other oral antidiabetic medications. Victoza works by stimulating the beta cells to release insulin only when blood glucose levels are high—because of this, Victoza is associated with a low rate of hypoglycemia. Victoza offers once-daily dosing and does not promote weight gain in the majority of patients.

Dosage Form:

Solution for subcutaneous injection, prefilled, multidose pen that delivers doses of 0.6, 1.2, or 1.8 mg (6 mg/mL, 3 mL). Two trade packages are available: 2-pen package for dispensing the 1.2-mg treatment dose, and 3-pen package for dispensing the 1.8-mg treatment dose.

For More Information:

www.victoza.com
877-4-VICTOZA (877-484-2869)


Fluzone High-Dose

Marketed by:
sanofi-aventis Inc (Bridgewater, NJ)

Indication:

The FDA approved a high-dose influenza vaccine, Fluzone High-Dose, for adults aged 65 years and older for the upcoming 2010-2011 influenza season. Fluzone High-Dose vaccine was specifically designed to generate a more robust immune response in people 65 years of age and older. The high-dose vaccine is an inactivated vaccine indicated for active immunization caused by influenza virus subtypes A and type B. The key finding in a phase 3 study of 3876 adults aged 65 years and older was that the new high-dose vaccine induced statistically significant increases in immune responses compared with the standard-dose vaccine in the study population.

Dosage Form:
Sterile suspension for intramuscular injection supplied in prefilled syringes, 0.5 mL, distinguished by a gray syringe plunger rod. Each 0.5-mL dose is formulated to contain a total of 180 mcg (60 mcg of each strain) of influenza virus hemagglutinin.

For More Information:

www.sanofipasteur.us


Ampyra

Marketed by:
Acorda Therapeutics Inc (Hawthorne, NY)

Indication:
Acorda Therapeutics Inc recently announced that it received marketing approval from the FDA for Ampyra (dalfampridine), an oral treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed—this is the first and only FDA-approved treatment addressing walking impairment. Ampyra, a potassium channel blocker, demonstrated efficacy in people with all 4 major types of MS (relapsing remitting, secondary progressive, progressive relapsing, and primary progressive). Ampyra can be used alone or with existing MS therapies, including immunomodulator drugs.

Dosage Form:

10-mg tablets

For More Information:

www.ampyra.com


Juvéderm XC


Marketed by:
Allergan Inc (Irvine, CA)

Indication:
Allergan Inc recently announced the FDA approval of Juvéderm XC dermal filler formulated with lidocaine, a new formulation of the currently approved Juvéderm. It is the first and only hyaluronic acid filler approved to last up to 1 year from initial treatment. The new Juvéderm XC formulation contains the local anesthetic lidocaine to provide patients with enhanced comfort during treatment of moderate-tosevere facial wrinkles and folds, such as the nasolabial folds that appear around the nose and mouth.

Dosage Form:
30-g needles for single-patient use and ready for injection (implantation)

For More Information:

www.juvederm.com
877-345-5372


Kalbitor

Marketed by:

Dyax Corp (Cambridge, MA)

Indication:

Dyax Corp announced that the FDA approved KALBITOR (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older. KALBITOR, a potent, selective, and reversible plasma kallikrein inhibitor, is the first subcutaneous treatment approved in the United States for HAE—a rare, genetic disorder characterized by severe, debilitating, and often painful swelling, which can occur in the abdomen, face, hands, feet, and airway.

Dosage Form:

Single-use glass vial containing 10 mg/mL of ecallantide as a solution for injection

For More Information:

www.kalbitor.com
888-4KALBITOR (888-452-5248)


Lamictal XR

Marketed by:
GlaxoSmithKline (Research Triangle Park, NC)

Indication:
The FDA approved Lamictal XR (lamotrigine extended-release tablets) as once-a-day, add-on therapy for patients with epilepsy aged 13 years and older with primary generalized tonic-clonic seizures. Patients with generalized tonic-clonic seizures currently taking immediate-release lamotrigine twice-daily can be converted directly to once-a-day lamotrigine XR using the same total daily dose.

Dosage Form:
Extended-release tablets: 25, 50, 100, and 200 mg

For More Information:
www.gsk.com


Spiriva Handihaler

Marketed by:
Boehringer Ingelheim Pharmaceuticals Inc (Ridgefield, CT) and Pfizer Inc (New York, NY)

Indication:
Boehringer Ingelheim Pharmaceuticals Inc and Pfizer Inc announced the FDA approval of a new indication for Spiriva HandiHaler (tiotropium bromide inhalation powder)—the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD). Spiriva HandiHaler is already indicated as a once-daily maintenance treatment for breathing problems associated with COPD, which includes chronic bronchitis, emphysema, or both. Treatment guidelines for COPD state that the reduction of exacerbations is a key goal. Symptoms associated with COPD include wheezing and difficulty breathing.

Dosage Form:
Spiriva capsules for oral inhalation: 18 mcg tiotropium powder, for use with HandiHaler device

For More Information:
www.spiriva.com


Vagifem

Marketed by:
Novo Nordisk (Princeton, NJ)

Indication:
Novo Nordisk reported that the FDA has approved a 10-mcg dose formulation of Vagifem (estradiol vaginal tablets) for the treatment of atrophic vaginitis due to menopause, which is a condition experienced by up to 75% of postmenopausal women. Vagifem 10 mcg is the lowest local estrogen therapy dose commercially available in the United States. Atrophic vaginitis (also known as vaginal atrophy) is directly related to the loss of estrogen associated with menopause. The product delivers estrogen directly to the vagina via a small tablet that is easy to insert by a ready-to-use applicator.

Dosage Form:
10-mcg tablet: 1 vaginal tablet contains 10.3 mcg estradiol hemihydrate equivalent to 10 mcg estradiol 25-mcg tablet: 1 vaginal tablet contains 25.8 mcg estradiol hemihydrate equivalent to 25 mcg estradiol

For More Information:
www.vagifem.com ■