Rx Product News

Kapidex

Marketed by: Takeda Pharmaceutical Company Ltd (Osaka, Japan) and its wholly owned subsidiary, Takeda Pharmaceuticals North America Inc (Deerfield, IL) Indication: January 30, 2009—The FDA approved Kapidex (dexlansoprazole) delayed-release capsules for the once-daily oral treatment of heartburn associated with symptomatic, nonerosive gastroesophageal reflux disease, the healing of erosive esophagitis, and the maintenance of healed erosive esophagitis. Kapidex is the first proton pump inhibitor with a dual delayed-release formulation designed to provide 2 separate releases of medication. The product decreases acid production by turning off many of the acid pumps in the stomach, thus helping to protect the esophagus from acidic reflux so that esophageal inflammation can heal. Dosage Form: Capsules: 30 and 60 mg For More Information: www.kapidex.com

Advair HFA

Marketed by:
Galderma Laboratories LP (Fort Worth, TX)

Indication:
January 8, 2009—GlaxoSmithKline announced that Advair HFA (fluticasone propionate and salmeterol HFA inhalation aerosol), which is an important treatment for asthma and is delivered by a metered dose inhaler, became available with a dose counter. Dose counters help ensure patients refill their medicine in a timely manner so they have medication on hand when they need it?helping them maintain proper asthma management. Advair is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist indicated for the maintenance treatment of asthma in patients 4 years of age and older, as well as maintenance treatment of airflow obstruction and reducing exacerbations in patients with chron ic obstructive pulmonary disease.

Dosage Form:
Oral inhalation powder: fluticasone propionate (100, 250, or 500 mcg) and salmeterol (50 mcg)

For More Information:
www.advair.com

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LoSeasonique

Marketed by:
Barr Pharmaceuticals Inc (Montvale, NJ)

Indication:
October 27, 2008—Barr Pharmaceuticals announced that the FDA approved its subsidiary Duramed Pharmaceuticals Inc?s new drug application for LoSeasonique (levonorgestrel/ethinyl estradiol tablets 0.10 mg/0.02 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive. LoSeasonique is the first lower-dose, extended-cycle oral contraceptive indicated for the prevention of pregnancy. Under the extended-cycle regimen, women take combination tablets containing 0.10 mg levonorgestrel/0.02 mg of ethinyl estradiol daily for 84 straight days, followed by 0.01 mg ethinyl estradiol tablets for 7 days. This regimen is designed to reduce the number of withdrawal bleeding periods from 13 to 4 per year.

Dosage Form:
Tablets: levonorgestrel/ethinyl estradiol tablets 0.10 mg/0.02 mg and ethinyl estradiol tablets 0.01 mg

For More Information:
www.barrlabs.com

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Premarin Vaginal Cream

Marketed by:
Wyeth Pharmaceuticals, a division of Wyeth (Collegeville, PA)

Indication:
November 13, 2008—Wyeth Pharmaceuticals announced that Premarin (conjugated estrogens) Vaginal Cream 0.5 g was approved for a new indication and a new less frequent twice-weekly dosing regimen to treat moderate-to-severe postmenopausal dyspareunia (painful sexual intercourse; experienced by more than 1 in 4 postmenopausal women). Premarin Vaginal Cream is the first vaginal estrogen therapy indicated for the treatment of moderate-to-severe dyspareunia due to menopause. A low-volume regimen of Premarin Vaginal Cream can treat painful intercourse due to menopause, restore vaginal tissue, and reverse changes in the vagina that occur with menopause.

Dosage Form:
Each gram contains 0.625 mg conjugated estrogens, USP

For More Information:
www.wyeth.com

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Ryzolt

Marketed by:
Labopharm Inc (Laval, Qu?bec, Canada) and Purdue Pharma LP (Stamford, CT)

Indication:
December 31, 2008—Labopharm announced that Ryzolt (tramadol HCl extended-release tablets) was approved by the FDA. Ryzolt is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. It is a once-daily formulation of the analgesic tramadol. Ryzolt is a centrally acting analgesic composed of a dual-matrix delivery system with both immediaterelease and extended-release characteristics.

Dosage Form:
Tablets: 100, 200, and 300 mg

For More Information:
www.labopharm.com

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Toviaz

Marketed by:
Pfizer Inc (New York, NY)

Indication:
October 31, 2008—Pfizer Inc said that the FDA approved Toviaz (fesoterodine fumarate) extended-release tablets for the treatment of overactive bladder (OAB) symptoms. New once-daily Toviaz can significantly reduce the number of urge urinary incontinence episodes and the frequency of urination over 24 hours, symptoms of OAB that can significantly impact patients? lives. Toviaz can help regulate the involuntary contractions of the bladder associated with OAB. These contractions cause frequent, sudden urges to urinate.

Dosage Form:
Tablets: 4 and 8 mg

For More Information:
www.TOVIAZ.com

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Ranexa

Marketed by:
CV Therapeutics Inc (Palo Alto, CA)

Indication:
November 6, 2008—The FDA approved a new, first-line indication for Ranexa (ranolazine extended-release tablets) for the treatment of chronic angina. The new labeling also provides information showing that Ranexa reduced arrhythmias, including ventricular arrhythmias, new-onset atrial fibrillation, and a potentially dangerous slow heartbeat known as bradycardia in patients with coronary artery disease. The new labeling also states that Ranexa reduces hemoglobin A1C in patients with diabetes. Ranexa is indicated for the treatment of chronic angina and may be used alone or in combination with traditional therapies, such as beta-blockers, calcium channel blockers, and nitrates, and cardioprotective treatments for cardiovascular disease, such as antiplatelet therapy, lipid-lowering therapy, angiotensin-converting enzyme inhibitors, and angiotensin receptor blockers.

Dosage Form:
Extended-release tablets: 500 and 1000 mg

For More Information:
www.ranexa.com

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Rosaclear System

Marketed by:
Obagi Medical Products Inc (Long Beach, CA)

Indication:
January 20, 2009—Obagi Medical Products announced the launch of the Obagi Rosaclear System?the first and only complete prescription-based system developed specifically for treating the signs and symptoms of rosacea. It is designed to reduce redness and flushing and treat papules and pustules to help rosacea patients achieve a clearer, calmer, and more balanced-looking complexion. The system includes a gentle cleanser; Metronidazole Topical Gel USP 0.75%, a prescription medication indicated for the treatment of papules and pustules associated with rosacea; and a hydrating complexion corrector, which uses calming agents to protect and moisturize the skin.

Dosage Form:
Extended-release tablets: 500 and 1000 mg

For More Information:
www.obagi.com

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