rx PRODUCT news
Marketed by:Eisai Inc(Woodcliff Lake, NJ) andPfizer Inc (New York, NY)
Indication:April 1, 2007?Eisai Inc andPfizer Inc announced theavailability of Aricept(donepezil hydrochloride)tablets in a 1000-countbottle. Once-a-day Aricept isindicated for the treatment of dementia of theAlzheimer's type, treating the full range ofAlzheimer's disease (AD)?mild, moderate, andsevere. The product was originally approved for thetreatment of mild-to-moderate AD in 1996, and itwas approved in October 2006 for the treatment ofsevere AD. The new 1000-count bottle of Aricept isavailable in 5-and 10-mg tablets. Both dosages willstill be offered in 30-and 90-count bottles and in100-count blister packaging.
Dosage form:Tablets: 5 and 10 mg
For more information:www.aricept.com888-999-9616
Marketed by:Wyeth Pharmaceuticals Inc(Collegeville,Pa)
Indication:March 26, 2007?Wyeth Pharmaceuticals announcedthat it received FDA approval for new productenhancements for BeneFIX Coagulation Factor IX(Recombinant). BeneFIX is a coagulation factor createdby using recombinant DNA technology to replaceclotting factor IX to stop or prevent bleeding in peoplewith hemophilia B who do not have enough factorIX of their own. It is indicated for the control andprevention of hemorrhagic episodes in patients withhemophilia B. One feature allows patients currentlyusing the most common dosage strength (1000international units [IU]) to use a lower volume of diluentto administer the product, which will lead to alower total volume of infused product. The other featuresinclude a 2000-IU dosage-strength vial, aneedleless reconstitution device, and a prefilled diluentsyringe.
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 ofOrtho-McNeilPharmaceuticals Inc
Indication:March 26, 2007?OrthoNeutrogena announced theintroduction of the Centany (mupirocin ointment)2% Kit for the topical treatment of impetigo due toStaphylococcus aureus and Streptococcus pyogenes.The kit contains a 30-g tube of Centany ointmentand a package of Johnson & Johnson gauzepads to cleanse and protect the affected area andhelp prevent the spread of infection.
Dosage form:Ointment: 30-g tube
For more information:www.orthoneutrogena.com877-738-4624
Marketed by:UCB Inc(Atlanta, Ga)
Indication:March 20, 2007?The FDAapproved the antiepileptic drugKeppra (levetiracetam) asadjunctive therapy in the treatmentof primary generalizedtonic-clonic seizures in adultsand children aged =6 yearswith idiopathic generalized epilepsy. Keppra tabletsand oral solution also are indicated as adjunctivetherapy in the treatment of partial-onset seizures inadults and children aged =4 years with epilepsy,and as adjunctive therapy in the treatment ofmyoclonic seizures in adults and adolescents aged=12 years with juvenile myoclonic epilepsy.
Dosage form:Tablets: 250, 500, 750, and 1000 mgOral solution: 100 mg/mL
For more information:www.keppra.com866-822-0068
Marketed by:Axcan Scandipharm Inc(Birmingham, Ala)
Indication:September 29, 2006?TheFDA issued an approval letterfor the new drug applicationfor Pylera (formerly known asHelizide). Pylera combines 3ingredients in 1 capsule forthe eradication of Helicobacterpylori, which is a bacterium now recognized asbeing the main cause of gastric and duodenalulcers. This triple therapy includes biscalcitratepotassium, metronidazole, and tetracyclinehydrochloride in each capsule. Pylera capsules, incombination with omeprazole, are indicated for thetreatment of patients with H pylori infection andduodenal ulcer disease (active or history of withinthe past 5 years) to eradicate H pylori.
Dosage form:Capsules: 140 mg biscalcitrate potassium, 125 mgmetronidazole, and 125 mg tetracycline hydrochloride
For more information:www.axcan.com
Marketed by:Pfizer Inc(New York, NY)
Indication:February 8, 2007?The FDAapproved new labeling forSutent (sunitinib malate), whichincludes first-line treatment ofadvanced renal cell carcinoma,a type of advanced kidney cancer,based on results of a large phase 3 trial thatshowed prolonged progression-free survival. Theproduct is a kinase inhibitor and is also indicatedfor the treatment of gastrointestinal stromal tumorafter disease progression on or intolerance to imatinibmesylate.
Dosage form:Capsules: 12.5, 25, and 50 mg
For more information:www.sutent.com800-879-3477
REAL-Time CGM Devices
Marketed by:Medtronic Inc(Minneapolis, Minn)
Indication:March 12, 2007?TheFDA approved new REAL-Time Continuous GlucoseMonitoring (CGM) devices for children andteenagers aged 7 to 17 years. These devices werepreviously approved only for adult patients, but theREAL-Time CGM will now be available in specificallydesigned pediatric models of the MiniMedParadigm REAL-Time System and Guardian REALTimeSystem. Medtronic REAL-Time CGM therapy isclinically proven to help patients monitor and bettercontrol their diabetes. This CGM technology displaysreal-time glucose values, trend graphs, anddirectional arrows, allowing patients to discoverhow diet, exercise, medication, and lifestyle affecttheir glucose levels.
For more information:www.medtronic.com800-328-2518
Marketed by:sanofi-aventis(Bridgewater, NJ)
Indication:March 13, 2007?Allegra (fexofenadine hydrochloride) OralSuspension became available for the treatmentof symptoms associated with seasonal allergies inpediatric patients aged 2 through 11 years withoutmaking them drowsy or causing impairment.Allegra Oral Suspension is berry-flavored and wasdesigned with children in mind as an easy-to-swallowliquid formulation. It also treats hives,which are caused by a reaction to an unknowntrigger in the upper layers of the skin.
Dosage form:Oral suspension: 30 mg/5 mL
For more information:www.allegra.com800-981-2491