Rx Product News

Pharmacy Times, Volume 0,0

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 FDAapproved Kapidex (dexlansoprazole) delayed-releasecapsules for the once-daily oral treatment of heartburnassociated with symptomatic, nonerosive gastroesophagealreflux disease, the healing of erosiveesophagitis, and the maintenance of healed erosiveesophagitis. Kapidex is the first proton pump inhibitorwith a dual delayed-release formulation designed toprovide 2 separate releases of medication. The productdecreases acid production by turning off many ofthe acid pumps in the stomach, thus helping to protectthe esophagus from acidic reflux so that esophagealinflammation 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—GlaxoSmithKlineannounced that Advair HFA (fluticasonepropionate and salmeterolHFA inhalation aerosol), which is animportant treatment for asthma andis delivered by a metered dose inhaler,became available with a dose counter. Dose countershelp ensure patients refill their medicine in a timely mannerso they have medication on hand when they needit?helping them maintain proper asthma management.Advair is a combination product containing a corticosteroidand a long-acting beta2-adrenergic agonist indicatedfor the maintenance treatment of asthma in patients 4years of age and older, as well as maintenance treatmentof airflow obstruction and reducing exacerbationsin 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

LoSeasonique

Marketed by:

Barr Pharmaceuticals Inc (Montvale, NJ)

Indication:

October 27, 2008—Barr Pharmaceuticals announcedthat the FDA approved its subsidiary DuramedPharmaceuticals Inc?s new drug application forLoSeasonique (levonorgestrel/ethinyl estradiol tablets0.10 mg/0.02 mg and ethinyl estradiol tablets 0.01 mg)extended-cycle oral contraceptive. LoSeasonique isthe first lower-dose, extended-cycle oral contraceptiveindicated for the prevention of pregnancy. Under theextended-cycle regimen, women take combination tabletscontaining 0.10 mg levonorgestrel/0.02 mg of ethinylestradiol daily for 84 straight days, followed by 0.01mg ethinyl estradiol tablets for 7 days. This regimen isdesigned to reduce the number of withdrawal bleedingperiods from 13 to 4 per year.

Dosage Form:

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

For More Information:

www.barrlabs.com

Premarin Vaginal Cream

Marketed by:

Wyeth Pharmaceuticals, a division of Wyeth (Collegeville, PA)

Indication:

November 13, 2008—Wyeth Pharmaceuticalsannounced that Premarin (conjugated estrogens) VaginalCream 0.5 g was approved for a new indication and anew less frequent twice-weekly dosing regimen to treatmoderate-to-severe postmenopausal dyspareunia (painfulsexual intercourse; experienced by more than 1 in 4postmenopausal women). Premarin Vaginal Cream is thefirst vaginal estrogen therapy indicated for the treatmentof moderate-to-severe dyspareunia due to menopause.A low-volume regimen of Premarin Vaginal Cream cantreat painful intercourse due to menopause, restore vaginaltissue, and reverse changes in the vagina that occurwith menopause.

Dosage Form:

Each gram contains 0.625 mg conjugated estrogens, USP

For More Information:

www.wyeth.com

Ryzolt

Marketed by:

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

Indication:

December 31, 2008—Labopharm announced thatRyzolt (tramadol HCl extended-release tablets) wasapproved by the FDA. Ryzolt is indicated for the managementof moderate to moderately severe chronicpain in adults who require around-the-clock treatmentof their pain for an extended period of time. Itis a once-daily formulation of the analgesic tramadol.Ryzolt is a centrally acting analgesic composed of adual-matrix delivery system with both immediatereleaseand extended-release characteristics.

Dosage Form:

Tablets: 100, 200, and 300 mg

For More Information:

www.labopharm.com

Toviaz

Marketed by:

Pfizer Inc (New York, NY)

Indication:

October 31, 2008—Pfizer Inc said that the FDA approvedToviaz (fesoterodine fumarate) extended-release tabletsfor the treatment of overactive bladder (OAB) symptoms.New once-daily Toviaz can significantly reducethe number of urge urinary incontinence episodes andthe frequency of urination over 24 hours, symptoms ofOAB that can significantly impact patients? lives. Toviazcan help regulate the involuntary contractions of thebladder associated with OAB. These contractions causefrequent, sudden urges to urinate.

Dosage Form:

Tablets: 4 and 8 mg

For More Information:

www.TOVIAZ.com

Ranexa

Marketed by:

CV Therapeutics Inc (Palo Alto, CA)

Indication:

November 6, 2008—The FDA approved a new, first-line indicationfor Ranexa (ranolazine extended-release tablets) for the treatment ofchronic angina. The new labeling also provides informationshowing that Ranexa reduced arrhythmias, includingventricular arrhythmias, new-onset atrial fibrillation,and a potentially dangerous slow heartbeat known asbradycardia in patients with coronary artery disease. Thenew labeling also states that Ranexa reduces hemoglobinA1C in patients with diabetes. Ranexa is indicatedfor the treatment of chronic angina and may be usedalone or in combination with traditional therapies, suchas 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 angiotensinreceptor blockers.

Dosage Form:

Extended-release tablets: 500 and 1000 mg

For More Information:

www.ranexa.com

Rosaclear System

Marketed by:

Obagi Medical Products Inc (Long Beach, CA)

Indication:

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

Dosage Form:

Extended-release tablets: 500 and 1000 mg

For More Information:

www.obagi.com

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