Rx Product News

Pharmacy Times, Volume 0, 0

Allegra (fexofenadine hydrochloride) Oral Suspension

Marketed by:Sanofi-aventis US(Bridgewater, NJ)

Indication:October 18, 2006—The FDA approved Allegra OralSuspension for the twice-daily treatment of symptomsassociated with seasonal allergies in pediatric patientsaged 2 to 11 years and for the treatment of chronicidiopathic urticaria in children aged 6 months to 11years. With this approval, a safe, effective, and nonimpairingseasonal allergy treatment option becomesavailable for pediatric populations as young as 2 yearsold. The product will have a berry flavor and be availablein an easy-to-swallow formulation that can helpreduce symptoms of seasonal allergies in children.

Dosage Form:Oral suspension: 30 mg/5 mL

For More Information:http://products.sanofi-aventis.us/allegra_oral/allegra.pdf

Colazal (balsalazide disodium) Capsules 750 mg

Marketed by:Salix Pharmaceuticals Ltd (Raleigh, NC)

Indication:December 20, 2006—The FDAapproved Colazal Capsules 750 mgfor use in pediatric patients between5 and 17 years of age with ulcerativecolitis. Colazal is an anti-inflammatorydrug already approved for the treatment of mild-tomoderateactive ulcerative colitis. With this additionalindication, Colazal is now the only 5-aminosalicyclicacid product approved for use in pediatric patients.

Dosage Form:Capsules: 750 mg

For More Information:www.salix.com

Humira (adalimumab)

Marketed by:Abbott Laboratories(Abbott Park, Ill)

Indication:November 14, 2006—Abbottannounced FDA approval of anexpanded indication for Humirathat includes inhibiting structuraljoint damage and improving physical function inpatients with psoriatic arthritis. Humira is alsoapproved for use in moderate-to-severe rheumatoidarthritis and active ankylosing spondylitis. This newapproval was obtained based on results from theAdalimumab Effectiveness in Psoriatic Arthritis Trial—the largest randomized, placebo-controlled biologictrial in psoriatic arthritis.

Dosage Form:Subcutaneous injection: 40 mg

For More Information:www.humira.com800-633-9110888-825-5249

Kadian (morphine sulfate) 80 mg

Marketed by:Alpharma Inc (Fort Lee, NJ)

Indication:October 30, 2006—Alpharma announcedFDA approval for its Kadian 80-mg capsule.Alpharma currently markets Kadian,a sustained-release morphine sulfateproduct, in 20-, 30-, 50-, 60-, and 100-mgdosages.With this additional dosage strength, physicianswill be better able to individualize their patient'streatments by offering more choices in managingtheir pain.

Dosage Form:Capsule: 80 mg

For More Information:www.alpharma.com

Mirapex (pramipexole dihydrochloride)

Marketed by:Boehringer Ingelheim PharmaceuticalsInc (Ridgefield, Conn)

Indication:November 10, 2006—The FDAapproved Mirapex tablets for thetreatment of moderate-to-severe primary RestlessLegs Syndrome (RLS), a common, yet often undiagnosed,neurological sensorimotor disorder. Symptomsof RLS may include an urge to move the legs accompaniedby burning, creeping, crawling, aching, tingling,or tugging sensations in the legs. RLS affects up to10% of the US adult population.

Dosage Form:Tablets: 0.125, 0.25, 0.5, 1, and 1.5 mg

For More Information:http://us.boehringer-ingelheim.com800-542-6257

NitroMist (nitroglycerin lingual aerosol)

Marketed by:NovaDel Pharma Inc(Flemington, NJ)

Indication:November 3, 2006—NitroMist was approved by theFDA for acute relief of an attack or acute prophylaxisof angina pectoris due to coronary artery disease. Thisis the first product approved that uses NovaDel's proprietaryoral spray technology. The North Americancommercial rights for NitroMist were licensed to ParPharmaceutical Companies Inc.

Dosage Form:Lingual aerosol: 400 μg per spray, 230 metered spraysper container

For More Information:www.novadel.com

Pylera (formerly Helizide)

Marketed by:Axcan Pharma Inc(Mont-Saint-Hillaire, Quebec)

Indication:September 29, 2006—Axcan Pharma Increceived an approval letter from the FDAfor the company's new drug application for Pylera.Pylera is a patented 3-in-1 capsule triple therapy, forthe eradication of Helicobacter pylori. Each Pyleracapsule contains biskalcitrate potassium (140 mg),metronidazole (125 mg), and tetracycline hydrochloride(125 mg).

Dosage Form:3 capsules qid + omeprazole 20 mg bid

For More Information:www.axcan.com

Reyataz (atazanavir sulfate)

Marketed by:Bristol-Myers Squibb Co(Princeton, NJ)

Indication:October 20, 2006—The FDA approveda new 300-mg single-capsule formulationof Reyataz for the treatment ofHIV-1 infection in adults as part of combination therapy.When taken once daily with ritonavir and food as part ofan anti-HIV drug regimen, the 300-mg Reyataz singlecapsuleformulation can replace two 150-mg capsulesfor patients who have previously received anti-HIV medicines;patients who will be receiving tenofovir disoproxilfumarate; and patients who have never taken anti-HIVmedicines that require Sustiva (efavirenz) as part of theiranti-HIV drug regimen.

Dosage Form:50 and 100 g

For More Information:www.connetics.com888-969-2628

Salex (6% w/w salicylic acid) Shampoo

Marketed by:Coria Laboratories Ltd(Fort Worth, Tex)

Indication:November 8, 2006—CoriaLaboratories announced the introductionof Salex Shampoo, a new prescription-strength, nonsteroidalshampoo indicated for the treatment of psoriasis andother hyperkeratotic scalp disorders. The shampoowas developed to provide sufficient levels of activeagent to effectively remove thick plaques and scalesassociated with scalp psoriasis.

Dosage Form:6-oz bottle

For More Information:www.corialabs.com866-819-9007

Nexium (esomeprazole magnesium)

Marketed by:AstraZeneca(Wilmington, Del)

Indication:October 24, 2006—AstraZeneca announced FDAapproval of a new formulation of its proton-pumpinhibitor, Nexium. Nexium for Delayed-release OralSuspension has been approved for the treatment ofgastroesophageal reflux disease (GERD), includingsymptomatic GERD, healing and maintenance of erosiveesophagitis, and risk reduction of nonsteroidalanti-inflammatory drug-associated gastric ulcers.The esomeprazole granules and inactive granulesused in this formulation are mixed with water toform a suspension and are given by oral, nasogastric,or gastric administration.

Dosage Form:Oral suspension: 20 or 40 mg

For More Information:www.nexium-us.com