Rx Product News

Pharmacy Times, Volume 0, 0

Betaseron (interferon beta-1b)

Marketed by:Berlex Inc(Wayne, NJ), a US affiliateof Schering AG (Germany)

Indication:October 23, 2006?The FDA expanded the indicationof Betaseron to include patients with multiple sclerosis(MS) who have experienced a first clinical episodeand have magnetic resonance imaging features consistentwith MS. Betaseron is indicated for the treatmentof relapsing forms of MS to reduce the frequencyof clinical exacerbations. Betaseron is the onlyhigh-dose, high-frequency interferon beta indicatedfor patients at the earliest stage of MS.

Dosage form:Subcutaneous injection: 0.25 mg

For more information:www.berlex.com888-BERLEX4 (888-237-5994)

Byetta (exenatide) injection

Marketed by:Amylin PharmaceuticalsInc (San Diego, Calif)and Eli Lilly and Co(Indianapolis, Ind)

Indication:December 22, 2006?TheFDA approved an additional indication for Byetta injection?as add-on therapy to improve blood sugar controlin people with type 2 diabetes who have notachieved adequate control on a thiazolidinedione.Byetta is the first in a new class of drugs calledincretin mimetics for the treatment of type 2 diabetes.Byetta demonstrates many of the same effects as thehuman incretin hormone glucagon-like peptide-1(GLP-1). GLP-1 improves blood sugar after food intakethrough multiple effects that work in concert on theintestine, liver, pancreas, and brain.

Dosage form:1.2-mL prefilled pen: 5 mcg per dose, 60 doses;2.4-mL prefilled pen: 10 mcg per dose, 60 doses

For more information:www.byetta.com800-868-1190

Celebrex (celecoxib)

Marketed by:Pfizer Inc(New York, NY)

Indication:December 18, 2006?The FDAapproved Celebrex for a newuse?the relief of the signs andsymptoms of juvenile rheumatoidarthritis (JRA) in patients 2 yearsof age and older. JRA, an autoimmunedisease affecting 30,000 to60,000 American children, isassociated with joint swelling,pain, decreased range of motion, and abnormalitiesof growth and development. Celebrex, a cyclooxygenase-2 selective nonsteroidal anti-inflammatory drug,was originally approved in 1998 for the relief of signsand symptoms of rheumatoid arthritis andosteoarthritis in adults.

Dosage form:Capsules: 100, 200, and 400 mg

For more information:www.pfizer.com888-678-2692

Desonate (desonide) gel 0.05%

Marketed by:SkinMedica Inc(Carlsbad, Calif)

Indication:October 23, 2006?TheFDA approved SkinMedica's new drug application forDesonate gel 0.05% for the treatment of mild-to-moderateatopic dermatitis. Desonate is a low-potencytopical steroid, free from alcohol, fragrance, or surfactants,which can be irritating or drying to the skin.Desonate is formulated in a proprietary water-basedhydrogel vehicle developed and patented by DowPharmaceutical Sciences Inc.

Dosage form:15-, 30-, and 60-g tubes

For more information:www.skinmedica.com877-867-0110

Epirubicin Hydrochloride for Injection

Marketed by:Mayne Pharma Inc(Paramus, NJ)

Indication:November 6, 2006?MaynePharma announced thelaunch of epirubicin hydrochloride for injection(lyophilized) 50 mg/vial (30 mL). The product is indicated as a component of adjuvant therapy in patientswith evidence of axillary node tumor involvement followingresection of primary breast cancer. MaynePharma's new drug application for epirubicin wasapproved by the FDA on September 15, 2006. Mayneintends in the near future to add epirubicin hydrochloridefor injection (lyophilized) packaged in a 200 mg/vial form (100-mL vial).

Dosage Form:50 mg/vial (30 mL)

For More Information:www.maynepharma.com

FluMist (influenza virus vaccine live, intranasal)

Marketed by:MedImmune Inc(Gaithersburg, Md)

Indication:January 8, 2007?The FDA provided greater access toFluMist with the approval of the new refrigerated formulationof the effective and well-tolerated influenzaprevention option in healthy children and adults fromages 5 to 49 years. The new formulation can be convenientlystored in a standard refrigerator rather thanfrozen, as previously required, making storage moreconvenient. FluMist has been marketed in a frozenformulation since its original FDA approval in 2003.

Dosage form:Intranasal delivery: 0.5 mL

For more information:www.flumist.com877-FLUMIST (877-358-6478)

Foradil Certihaler (formoterol fumarate inhalation powder)

Marketed by:SkyePharma PLC(London, UK) andNovartis PharmaceuticalsCorp (East Hanover, NJ)

Indication:December 18, 2006?SkyePharma announced thatthe FDA approved Foradil Certihaler for the treatmentof asthma. The product is a multidose dry powderinhaler version of the long-acting bronchodilator formoterol.Foradil Certihaler was codeveloped bySkyePharma and Novartis. This approval follows theapprovable letter issued by the FDA in April 2006.

Dosage form:12 mcg

For more information:www.foradil.us

Ziana (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel

Marketed by:Medicis (Scottsdale, Ariz) and Dow PharmaceuticalSciences Inc (Petaluma, Calif)

Indication:November 8, 2006?The FDA approved Ziana Gel.Ziana Gel is the first and only combination of clindamycinand tretinoin approved for once-daily use forthe topical treatment of acne vulgaris in patients 12years or older. It also is the first and only approvedacne product to combine an antibiotic and a retinoid.

Dosage form:30-and 60-g tubes

For more information:www.medicis.com800-550-5115

Invega (paliperidone) Extended-release Tablets

Marketed by:Janssen LP(Titusville, NJ)

Indication:December 20, 2006?The FDAapproved a new atypical antipsychoticfor the treatment of schizophrenia?Invega Extended-releaseTablets. The once-daily oral medicationis specifically designed to deliver paliperidone?the active ingredient derived from risperidone?through the innovative OROS extended-release technology,demonstrating powerful efficacy and aproven safety and tolerability profile. Invega is thefirst new prescription treatment for schizophrenia tobe approved by the FDA since 2003.

Dosage form:Tablets: 3, 6, and 9 mg

For more information:www.invega.com800-526-7736