rx PRODUCT news
Fentora (fentanyl buccal tablet)
Marketed by:Cephalon Inc (Frazer, Pa)
Indication:September 25, 2006?Cephalon receivedapproval from the FDA to market Fentora (CII) for themanagement of breakthrough pain in patients withcancer who are already receiving and who are tolerantto opioid therapy for their underlying persistentcancer pain. Fentora is the first and only buccal tabletapproved for this indication.
Dosage Form:Tablets: 100, 200, 400, 600, and 800 mcg
For More Information:www.cephalon.com800-896-5855
FluLaval (influenza virus vaccine)
Marketed by:GlaxoSmithKline(Philadelphia, Pa)
Indication:October 5, 2006?The FDA approved FluLaval, underfast-track review status, for the active immunizationof adults 18 years of age and older against influenzadisease caused by influenza virus types A and B. Theapproval of FluLaval is a major step toward increasingthe supply of flu vaccine.
Dosage Form:10 0.5-mL doses in a 5-mL vial
For More Information:www.gsk.com888-825-5249
Marketed by:GlaxoSmithKline(Research TrianglePark, NC)
Indication:September 25, 2006?The FDA approved a new indicationfor the antiseizure medicine Lamictal. Lamictaltablets may now be used to treat primary generalizedtonic-clonic (PGTC) seizures (also known as "grandmal" seizures). The tablets are indicated as add-ontherapy to treat PGTC seizures in children aged 2 andolder, as well as adults. Lamictal is also approved asmaintenance therapy for adults with bipolar I disorder.
Dosage Form:Tablets: 25, 100, 150, and 200 mg
For More Information:www.gsk.com888-825-5249
Marketed by:Schering-Plough(Kenilworth, NJ)
Indication:September 18, 2006?TheFDA approved Noxafil OralSuspension for the prophylaxisof invasive Aspergillusand Candida infections inpatients 13 years of age and older, who are at highrisk of developing these infections due to beingseverely immunocompromised, such as hematopoieticstem cell transplant recipients with graft-versushostdisease, or those with hematologic malignancieswith prolonged neutropenia from chemotherapy. Thisrepresents the first and only approval for an antifungalagent used to prevent invasive fungal infectionscaused by Aspergillus species.
Dosage Form:Oral suspension: 200 mg/5 mL
For More Information:www.schering-plough.com908-298-4000
Marketed by:Centocor Inc(Horsham, Pa)
Indication:September 27, 2006?TheFDA approved an additionalindication for Remicade?for the treatment of adultpatients with chronic severe plaque psoriasis who arecandidates for systemic therapy and when other systemictherapies are medically less appropriate.Remicade is the first and only anti-tumor necrosisfactor-alpha treatment to receive 13 FDA approvalsfor inflammatory diseases across gastroenterology,rheumatology, and dermatology.
Dosage Form:Sterile, white, lypholized concentrate containing 100mg infliximab in a single-use vial
For More Information:www.remicade.com888-779-9769
Marketed by:Janssen LP (Titusville, NJ)
Indication:October 6, 2006?The FDAapproved Risperdal, anadult antipsychotic oraltablet, for the symptomatictreatment of irritability in autistic children and adolescents.This approval represents the first use of a drugto treat behaviors associated with autism in children.
Dosage Form:Tablets: 0.25, 0.5, 1, 2, 3, and 4 mg
For More Information:www.risperdal.com800-526-7736
Marketed by:Amgen Inc (ThousandOaks, Calif)
Indication:September 27, 2006?The FDA approvedVectibix after priorityreview. Vectibix is the first entirely human monoclonalantibody for the treatment of patients with epidermalgrowth factor receptor-expressing metastatic colorectalcancer after disease progression while on orfollowing fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Dosage Form:Sterile, colorless, preservative-free solution containing20 mg/mL panitumumab in a single-use vial
For More Information:www.amgen.com800-772-6436
Verdeso (desonide) Foam, 0.05%
Marketed by:Connetics Corp (Palo Alto, Calif)
Indication:September 20, 2006?ConneticsCorp announced FDA approval ofVerdeso Foam, 0.05%, for the treatmentof mild-to-moderate atopicdermatitis. The product, previouslyknown as Desilux, is a low-potencytopical steroid and is the first approved product formulatedin Connetics' proprietary VersaFoam-EFemulsion formulation foam vehicle.
Dosage Form:50 and 100 g
For More Information:www.connetics.com888-969-2628
Xolegel (ketoconazole, USP) Gel, 2%
Marketed by:BarrierTherapeutics Inc(Princeton, NJ)
Indication:July 28, 2006?Xolegel gel, 2%, was approved by theFDA for the topical treatment of seborrheic dermatitisin immunocompetent adults and children 12 years ofage and older. Xolegel, formerly known as Sebazole, isa topical formulation of 2.0% ketoconazole, an antifungalagent, in a waterless gel for once-daily application.Xolegel is the first prescription gel formulation ofketoconazole approved in the United States.
Dosage Form:Gel: 2-g sample tube; 15-g aluminum tube
For More Information:www.barriertherapeutics.com866-440-5508
YAZ (3 mg drospirenone/20 mcg ethinyl estradiol)
Marketed by:Berlex Inc(Wayne, NJ)
Indication:October 5, 2006?The FDA has approved YAZ as the first and only oralcontraceptive shown to be clinically effective for thetreatment of emotional and physical symptoms ofpremenstrual dysphoric disorder in women whochoose to use an oral contraceptive. YAZ, approvedfor the prevention of pregnancy in March 2006, isthe first birth-control pill to combine ethinyl estradiolwith the innovative progestin drospirenone in a 24-day active hormone pill regimen.
Dosage Form:Tablets: 24 active tablets (3 mg drospirenone/20mcg ethinyl estradiol) and 4 inert tablets
For More Information:www.berlex.com888-237-5394