/publications/issue/2007/2007-02/2007-02-6271

Rx Product News

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Betaseron (interferon beta-1b)

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

Indication: October 23, 2006?The FDA expanded the indication of Betaseron to include patients with multiple sclerosis (MS) who have experienced a first clinical episode and have magnetic resonance imaging features consistent with MS. Betaseron is indicated for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. Betaseron is the only high-dose, high-frequency interferon beta indicated for patients at the earliest stage of MS.

Dosage form: Subcutaneous injection: 0.25 mg

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


Byetta (exenatide) injection

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

Indication: December 22, 2006?The FDA approved an additional indication for Byetta injection?as add-on therapy to improve blood sugar control in people with type 2 diabetes who have not achieved adequate control on a thiazolidinedione. Byetta is the first in a new class of drugs called incretin mimetics for the treatment of type 2 diabetes. Byetta demonstrates many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the intestine, 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.com 800-868-1190


Celebrex (celecoxib)

Marketed by: Pfizer Inc (New York, NY)

Indication: December 18, 2006?The FDA approved Celebrex for a new use?the relief of the signs and symptoms of juvenile rheumatoid arthritis (JRA) in patients 2 years of age and older. JRA, an autoimmune disease affecting 30,000 to 60,000 American children, is associated with joint swelling, pain, decreased range of motion, and abnormalities of growth and development. Celebrex, a cyclooxygenase- 2 selective nonsteroidal anti-inflammatory drug, was originally approved in 1998 for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis in adults.

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

For more information: www.pfizer.com 888-678-2692


Desonate (desonide) gel 0.05%

Marketed by: SkinMedica Inc (Carlsbad, Calif)

Indication: October 23, 2006?The FDA approved SkinMedica's new drug application for Desonate gel 0.05% for the treatment of mild-to-moderate atopic dermatitis. Desonate is a low-potency topical steroid, free from alcohol, fragrance, or surfactants, which can be irritating or drying to the skin. Desonate is formulated in a proprietary water-based hydrogel vehicle developed and patented by Dow Pharmaceutical Sciences Inc.

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

For more information: www.skinmedica.com 877-867-0110


Epirubicin Hydrochloride for Injection

Marketed by: Mayne Pharma Inc (Paramus, NJ)

Indication: November 6, 2006?Mayne Pharma announced the launch of epirubicin hydrochloride for injection (lyophilized) 50 mg/vial (30 mL). The product is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. Mayne Pharma's new drug application for epirubicin was approved by the FDA on September 15, 2006. Mayne intends in the near future to add epirubicin hydrochloride for 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 to FluMist with the approval of the new refrigerated formulation of the effective and well-tolerated influenza prevention option in healthy children and adults from ages 5 to 49 years. The new formulation can be conveniently stored in a standard refrigerator rather than frozen, as previously required, making storage more convenient. FluMist has been marketed in a frozen formulation since its original FDA approval in 2003.

Dosage form: Intranasal delivery: 0.5 mL

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


Foradil Certihaler (formoterol fumarate inhalation powder)

Marketed by: SkyePharma PLC (London, UK) and Novartis Pharmaceuticals Corp (East Hanover, NJ)

Indication: December 18, 2006?SkyePharma announced that the FDA approved Foradil Certihaler for the treatment of asthma. The product is a multidose dry powder inhaler version of the long-acting bronchodilator formoterol. Foradil Certihaler was codeveloped by SkyePharma and Novartis. This approval follows the approvable 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 Pharmaceutical Sciences Inc (Petaluma, Calif)

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

Dosage form: 30-and 60-g tubes

For more information: www.medicis.com 800-550-5115


Invega (paliperidone) Extended-release Tablets

Marketed by: Janssen LP (Titusville, NJ)

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

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

For more information: www.invega.com 800-526-7736