Marketed by: Eisai Inc (Woodcliff Lake, NJ) and Pfizer Inc (New York, NY)
Indication: April 1, 2007?Eisai Inc and Pfizer Inc announced the availability of Aricept (donepezil hydrochloride) tablets in a 1000-count bottle. Once-a-day Aricept is indicated for the treatment of dementia of the Alzheimer's type, treating the full range of Alzheimer's disease (AD)?mild, moderate, and severe. The product was originally approved for the treatment of mild-to-moderate AD in 1996, and it was approved in October 2006 for the treatment of severe AD. The new 1000-count bottle of Aricept is available in 5-and 10-mg tablets. Both dosages will still be offered in 30-and 90-count bottles and in 100-count blister packaging.
Dosage form: Tablets: 5 and 10 mg
For more information: www.aricept.com 888-999-9616
Marketed by: Wyeth Pharmaceuticals Inc (Collegeville, Pa)
Indication: March 26, 2007?Wyeth Pharmaceuticals announced that it received FDA approval for new product enhancements for BeneFIX Coagulation Factor IX (Recombinant). BeneFIX is a coagulation factor created by using recombinant DNA technology to replace clotting factor IX to stop or prevent bleeding in people with hemophilia B who do not have enough factor IX of their own. It is indicated for the control and prevention of hemorrhagic episodes in patients with hemophilia B. One feature allows patients currently using the most common dosage strength (1000 international units [IU]) to use a lower volume of diluent to administer the product, which will lead to a lower total volume of infused product. The other features include a 2000-IU dosage-strength vial, a needleless reconstitution device, and a prefilled diluent syringe.
Dosage form: Single-use vials: 250, 500, 1000, or 2000 IU
For more information: www.hemophiliavillage.com
Centany 2% Kit
Marketed by: OrthoNeutrogena (Los Angeles, Calif), a division of Ortho-McNeil Pharmaceuticals Inc
Indication: March 26, 2007?OrthoNeutrogena announced the introduction of the Centany (mupirocin ointment) 2% Kit for the topical treatment of impetigo due to Staphylococcus aureus and Streptococcus pyogenes. The kit contains a 30-g tube of Centany ointment and a package of Johnson & Johnson gauze pads to cleanse and protect the affected area and help prevent the spread of infection.
Dosage form: Ointment: 30-g tube
For more information: www.orthoneutrogena.com 877-738-4624
Marketed by: UCB Inc (Atlanta, Ga)
Indication: March 20, 2007?The FDA approved the antiepileptic drug Keppra (levetiracetam) as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children aged =6 years with idiopathic generalized epilepsy. Keppra tablets and oral solution also are indicated as adjunctive therapy in the treatment of partial-onset seizures in adults and children aged =4 years with epilepsy, and as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents aged =12 years with juvenile myoclonic epilepsy.
Dosage form: Tablets: 250, 500, 750, and 1000 mg Oral solution: 100 mg/mL
For more information: www.keppra.com 866-822-0068
Marketed by: Axcan Scandipharm Inc (Birmingham, Ala)
Indication: September 29, 2006?The FDA issued an approval letter for the new drug application for Pylera (formerly known as Helizide). Pylera combines 3 ingredients in 1 capsule for the eradication of Helicobacter pylori, which is a bacterium now recognized as being the main cause of gastric and duodenal ulcers. This triple therapy includes biscalcitrate potassium, metronidazole, and tetracycline hydrochloride in each capsule. Pylera capsules, in combination with omeprazole, are indicated for the treatment of patients with H pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H pylori.
Dosage form: Capsules: 140 mg biscalcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride
For more information: www.axcan.com
Marketed by: Pfizer Inc (New York, NY)
Indication: February 8, 2007?The FDA approved new labeling for Sutent (sunitinib malate), which includes first-line treatment of advanced renal cell carcinoma, a type of advanced kidney cancer, based on results of a large phase 3 trial that showed prolonged progression-free survival. The product is a kinase inhibitor and is also indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate.
Dosage form: Capsules: 12.5, 25, and 50 mg
For more information: www.sutent.com 800-879-3477
REAL-Time CGM Devices
Marketed by: Medtronic Inc (Minneapolis, Minn)
Indication: March 12, 2007?The FDA approved new REAL-Time Continuous Glucose Monitoring (CGM) devices for children and teenagers aged 7 to 17 years. These devices were previously approved only for adult patients, but the REAL-Time CGM will now be available in specifically designed pediatric models of the MiniMed Paradigm REAL-Time System and Guardian REALTime System. Medtronic REAL-Time CGM therapy is clinically proven to help patients monitor and better control their diabetes. This CGM technology displays real-time glucose values, trend graphs, and directional arrows, allowing patients to discover how diet, exercise, medication, and lifestyle affect their glucose levels.
For more information: www.medtronic.com 800-328-2518
Marketed by: sanofi-aventis (Bridgewater, NJ)
Indication: March 13, 2007?Allegra (fexofenadine hydrochloride) Oral Suspension became available for the treatment of symptoms associated with seasonal allergies in pediatric patients aged 2 through 11 years without making them drowsy or causing impairment. Allegra Oral Suspension is berry-flavored and was designed with children in mind as an easy-to-swallow liquid formulation. It also treats hives, which are caused by a reaction to an unknown trigger in the upper layers of the skin.
Dosage form: Oral suspension: 30 mg/5 mL
For more information: www.allegra.com 800-981-2491