RX PRODUCT News

Abilify

Marketed by:

Otsuka Pharmaceutical Co Ltd (Tokyo, Japan) and Bristol-Myers Squibb Co (Princeton, NJ)

Indication:

February 29, 2008—Otsuka Pharmaceutical Co Ltd and Bristol-Myers Squibb Co announced today that the FDA approved a supplemental new drug application for Abilify (aripiprazole) for the acute treatment of manic and mixed episodes associated with bipolar I disorder, with or without psychotic features in pediatric patients aged 10 to 17 years. Abilify, the first and only available dopamine partial agonist, also has been approved for acute and maintenance treatment of manic and mixed episodes associated with bipolar I disorder with or without psychotic features in adults since September 2004 and March 2005, respectively.

Dosage Form:

Tablets: 2, 5, 10, 15, 20, and 30 mg; also available are 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

Arcalyst

Marketed by:

Regeneron Pharmaceuticals Inc (Tarrytown, NY)

Indication:

February 27, 2008—Regeneron Pharmaceuticals Inc announced that the FDA granted marketing approval for Arcalyst (rilonacept) Injection for subcutaneous use, an interleukin-1 (IL-1) blocker, for the treatment of cryopyrinassociated periodic syndromes (CAPS), including familial cold auto-inflammatory syndrome and Muckle-Wells syndrome in adults and children aged 12 and older.

Arcalyst is the only therapy approved for patients with CAPS, a group of rare, inherited, auto-inflammatory conditions characterized by lifelong, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli. Arcalyst is a targeted inhibitor of IL-1, the key driver of inflammation in CAPS.

Dosage Form:

Sterile, single-use, 20-mL glass vial containing 220 mg of rilonacept as a lyophilized powder for reconstitution

For More Information:

www.regeneron.com

Asmanex Twisthaler

Marketed by:

Schering-Plough Corp (Kenilworth, NJ)

Indication:

February 4, 2008—Schering-Plough Corp announced that the FDA approved Asmanex Twisthaler 110 mcg (mometasone furoate inhalation powder) for the maintenance treatment of asthma as a preventive therapy in patients aged 4 to 11. Asmanex is the first and only inhaled corticosteroid approved for oncedaily dosing in children as young as age 4. Asmanex 220 mcg was approved on March 31, 2005, by the FDA for maintenance treatment of asthma as preventive therapy in patients aged 12 and older. Asthma is the most common chronic condition among children, and it is the cause of almost 3 million physician visits and 200,000 hospitalizations among children each year. Taken every day, maintenance inhalers help prevent asthma symptoms.

Dosage Form:

Twisthaler: 110 and 220 mcg

For More Information:

www.asmanex.com/asmanex/application

Granisol Oral Solution

Marketed by:

Hawthorn Pharmaceuticals Inc (Madison, MS)

Indication:

March 12, 2008—Hawthorn Pharmaceuticals Inc announced that the FDA approved Granisol (granisetron HCl) Oral Solution. Granisol is the AA-rated equivalent of Roche's Kytril Oral Solution. Granisol is an oral solution indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin and with radiation, including total body irradiation and fractionated abdominal radiation.

Dosage Form:

Oral Solution: 2 mg/10 mL in 30-mL amber glass bottles with child-resistant closures

For More Information:

www.hawthornrx.com

Hot Rx

AlleRx Dose Pack

Marketed by:

Cornerstone BioPharma Inc (Cary, NC)

Indication:

March 5, 2008—Cornerstone BioPharma announced the addition of a new dose pack to its allergic rhinitis AlleRx Dose Pack product line. The new AlleRx Dose Pack is indicated for the temporary relief of symptoms associated with allergic rhinitis. The AlleRx Dose Pack family has a patented AM/PM dosing, for alert days and restful nights, which provides symptomatic relief of allergic rhinitis without inconvenient side effects. In general, decongestants have not been used at night because they have been shown to cause alertness and counter sleep.

Dosage Form:

10-day supply (AlleRx Dose Pack) and a 30-day supply (AlleRx Dose Pack 30); AM dose: 120 mg pseudoephedrine HCl and 2.5 mg methscopolamine nitrate; PM dose: 10 mg phenylephrine HCl, 8 mg chlorpheniramine maleate, and 2.5 mg methscopolamin enitrate

For More Information:

www.cornerstonebiopharma.com

Nexium

Marketed by:

AstraZeneca (Wilmington, DE)

Indication:

February 28, 2008—AstraZeneca announced the FDA approval of Nexium (esomeprazole magnesium) in children aged 1 to 11 for the shortterm treatment of gastroesophageal reflux disease (GERD) for up to 8 weeks, helping to address an important unmet need for pediatric patients. Nexium received approval in April 2006 for adolescents aged 12 to 17 for the treatment of GERD, a condition in which the contents of the stomach back up into the esophagus. Nexium is indicated in the healing of erosive esophagitis, maintenance of healing of erosive esophagitis, and symptomatic GERD.

Dosage Form:

Capsules: 20 and 40 mg; also available in delayed-release oral suspension, which is supplied in unit-dose packages of 30: 20- and 40-mg packets

For More Information:

www.NEXIUM-US.com

800-236-9933

Pristiq

Marketed by:

Wyeth Pharmaceuticals (Madison, NJ)

Indication:

February 29, 2008—Wyeth Pharmaceuticals announced that the FDA approved Pristiq (desvenlafaxine), a structurally novel, once-daily serotoninnorepinephrine reuptake inhibitor, to treat adult patients with major depressive disorder (MDD). The drug was approved as a oncedaily 50-mg dose that does not require titration, which allows physicians to start patients at the recommended therapeutic dose. It was not approved for pediatric patients. The effectiveness of Pristiq was established in 4 eight-week, randomized, double-blind, placebocontrolled fixed-dose studies in adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders criteria for MDD.

Dosage Form:

Tablets: 50 and 100 mg

For More Information:

www.pristiq.com

Xyzal

Marketed by:

UCB Inc (Brussels, Belgium) and sanofi-aventis US LLC (Bridgewater, NJ)

Indication:

February 19, 2008—UCB and sanofi-aventis announced that the FDA approved a new drug application for Xyzal (levocetirizine dihydrochloride) 0.5 mg/mL oral solution, an antihistamine indicated for the relief of symptoms associated with indoor and outdoor allergies (seasonal and perennial allergic rhinitis), as well as the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria. On May 25, 2007, Xyzal tablets were approved by the FDA, and both formulations are now approved for use in adults and children aged 6 years and older.

Dosage Form:

Oral solution: 0.5 mg/mL; tablets: 5 mg

For More Information:

www.xyzal.com