Allegra (fexofenadine hydrochloride) Oral Suspension
Marketed by: Sanofi-aventis US (Bridgewater, NJ)
Indication: October 18, 2006The FDA approved Allegra Oral Suspension for the twice-daily treatment of symptoms associated with seasonal allergies in pediatric patients aged 2 to 11 years and for the treatment of chronic idiopathic urticaria in children aged 6 months to 11 years. With this approval, a safe, effective, and nonimpairing seasonal allergy treatment option becomes available for pediatric populations as young as 2 years old. The product will have a berry flavor and be available in an easy-to-swallow formulation that can help reduce 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, 2006The FDA approved Colazal Capsules 750 mg for use in pediatric patients between 5 and 17 years of age with ulcerative colitis. Colazal is an anti-inflammatory drug already approved for the treatment of mild-tomoderate active ulcerative colitis. With this additional indication, Colazal is now the only 5-aminosalicyclic acid product approved for use in pediatric patients.
Dosage Form: Capsules: 750 mg
For More Information: www.salix.com
Marketed by: Abbott Laboratories (Abbott Park, Ill)
Indication: November 14, 2006Abbott announced FDA approval of an expanded indication for Humira that includes inhibiting structural joint damage and improving physical function in patients with psoriatic arthritis. Humira is also approved for use in moderate-to-severe rheumatoid arthritis and active ankylosing spondylitis. This new approval was obtained based on results from the Adalimumab Effectiveness in Psoriatic Arthritis Trial the largest randomized, placebo-controlled biologic trial in psoriatic arthritis.
Dosage Form: Subcutaneous injection: 40 mg
For More Information: www.humira.com 800-633-9110 888-825-5249
Kadian (morphine sulfate) 80 mg
Marketed by: Alpharma Inc (Fort Lee, NJ)
Indication: October 30, 2006Alpharma announced FDA approval for its Kadian 80-mg capsule. Alpharma currently markets Kadian, a sustained-release morphine sulfate product, in 20-, 30-, 50-, 60-, and 100-mg dosages.With this additional dosage strength, physicians will be better able to individualize their patient's treatments by offering more choices in managing their pain.
Dosage Form: Capsule: 80 mg
For More Information: www.alpharma.com
Mirapex (pramipexole dihydrochloride)
Marketed by: Boehringer Ingelheim Pharmaceuticals Inc (Ridgefield, Conn)
Indication: November 10, 2006The FDA approved Mirapex tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS), a common, yet often undiagnosed, neurological sensorimotor disorder. Symptoms of RLS may include an urge to move the legs accompanied by burning, creeping, crawling, aching, tingling, or tugging sensations in the legs. RLS affects up to 10% 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.com 800-542-6257
NitroMist (nitroglycerin lingual aerosol)
Marketed by: NovaDel Pharma Inc (Flemington, NJ)
Indication: November 3, 2006NitroMist was approved by the FDA for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. This is the first product approved that uses NovaDel's proprietary oral spray technology. The North American commercial rights for NitroMist were licensed to Par Pharmaceutical Companies Inc.
Dosage Form: Lingual aerosol: 400 μg per spray, 230 metered sprays per container
For More Information: www.novadel.com
Pylera (formerly Helizide)
Marketed by: Axcan Pharma Inc (Mont-Saint-Hillaire, Quebec)
Indication: September 29, 2006Axcan Pharma Inc received an approval letter from the FDA for the company's new drug application for Pylera. Pylera is a patented 3-in-1 capsule triple therapy, for the eradication of Helicobacter pylori. Each Pylera capsule 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, 2006The FDA approved a new 300-mg single-capsule formulation of Reyataz for the treatment of HIV-1 infection in adults as part of combination therapy. When taken once daily with ritonavir and food as part of an anti-HIV drug regimen, the 300-mg Reyataz singlecapsule formulation can replace two 150-mg capsules for patients who have previously received anti-HIV medicines; patients who will be receiving tenofovir disoproxil fumarate; and patients who have never taken anti-HIV medicines that require Sustiva (efavirenz) as part of their anti-HIV drug regimen.
Dosage Form: 50 and 100 g
For More Information: www.connetics.com 888-969-2628
Salex (6% w/w salicylic acid) Shampoo
Marketed by: Coria Laboratories Ltd (Fort Worth, Tex)
Indication: November 8, 2006Coria Laboratories announced the introduction of Salex Shampoo, a new prescription- strength, nonsteroidal shampoo indicated for the treatment of psoriasis and other hyperkeratotic scalp disorders. The shampoo was developed to provide sufficient levels of active agent to effectively remove thick plaques and scales associated with scalp psoriasis.
Dosage Form: 6-oz bottle
For More Information: www.corialabs.com 866-819-9007
Nexium (esomeprazole magnesium)
Marketed by: AstraZeneca (Wilmington, Del)
Indication: October 24, 2006AstraZeneca announced FDA approval of a new formulation of its proton-pump inhibitor, Nexium. Nexium for Delayed-release Oral Suspension has been approved for the treatment of gastroesophageal reflux disease (GERD), including symptomatic GERD, healing and maintenance of erosive esophagitis, and risk reduction of nonsteroidal anti-inflammatory drug-associated gastric ulcers. The esomeprazole granules and inactive granules used in this formulation are mixed with water to form 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