Rx Product News

: Eli Lilly and Co (Indianapolis, IN) and Acrux (Melbourne, Australia)

Indication: Eli Lilly and Co and Acrux announced the FDA approval of once-daily Axiron (testosterone) topical solution CIII. Axiron is indicated for replacement therapy in men for certain conditions associated with a deficiency or absence of endogenous testosterone, including congenital or acquired primary hypogonadism and congenital or acquired hypogonadotropic hypogonadism. Axiron is the first testosterone topical solution approved for application via an underarm applicator. The safety and efficacy of Axiron in men younger than 18 years have not been established.

Dosage Form: Topical solution in a metered-dose applicator: 1 pump actuation delivers testosterone 30 mg in 1.5 mL of solution For More Information: www.lilly.com www.acrux.com.au

Shire plc (Philadephia, PA)

Indication: Shire plc announced that Vyvanse (lisdexamfetamine dimesylate) Capsules CII were approved by the FDA for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years. Vyvanse is a prodrug of the central nervous system stimulant dextroamphetamine. It is already approved for the treatment of ADHD in children aged 6 to 12 years and adults. The recommended dose for adult and pediatric patients aged 6 to 17 years is 30 mg once daily in the morning.

Dosage Form: Capsules: 20, 30, 40, 50, 60, and 70 mg

For More Information: www.vyvanse.com

Alkermes, Inc (Waltham, MA)

Indication: Alkermes, Inc announced the FDA approval of Vivitrol (naltrexone for extendedrelease injectable suspension) for the prevention of relapse to opioid dependence following opioid detoxification. Vivitrol is the first and only nonnarcotic, nonaddictive, once-monthy medication approved for the treatment of opioid dependence. The product is administered as an intramuscular injection using one of the customized needles provided in the carton. Vivitrol was approved by the FDA in 2006 for the treatment of alcohol dependence as part of a comprehensive management program that includes psychosocial support.

Dosage Form: Injectable suspension: naltrexone 380 mg and diluent 4 mL

For More Information: www.vivitrol.com 800-VIVITROL (848-4876)

Bristol-Myers Squibb Co (Princeton, NJ) and AstraZeneca (London, England)

Indication: Kombiglyze XR (saxagliptin and metformin hydrochloride [HCl] extended release) tablets are a combination dipeptidyl peptidase-4 inhibitor and biguanide product indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate. Kombiglyze XR should be taken once daily with the evening meal, and should be swallowed whole. The product is not indicated for patients with type 1 diabetes or diabetic ketoacidosis and has not been studied in combination with insulin.

Dosage Form: Tablets (saxagliptin/metformin HCl extended release): 5 mg/500 mg, 5 mg/1000 mg, 2.5 mg/1000 mg

For More Information: www.bms.com; www.astrazeneca-us.com

Stiefel Laboratories Inc (Research Triangle Park, NC)

Indication: Stiefel, a GlaxoSmithKline company, announced the FDA approval of Sorilux (calcipotriene) Foam 0.005% for the treatment of plaque psoriasis in patients aged 18 and older. Plaque psoriasis is a chronic, noncontagious, inflammatory skin condition that appears as red patches covered with silvery flakes. Sorilux Foam contains the vitamin D analog calcipotriene, a synthetic compound similar to natural vitamin D3, and is indicated for topical use only.

Dosage Form: Topical foam: 0.005%

For More Information: www.soriluxfoam.com

Talecris Biotherapeutics (Research Triangle Park, NC)

Indication: Talecris announced that the FDA approved Gamunex-C (Immune Globulin Injection [Human], 10% Caprylate/Chromatography Purified) for subcutaneous administration in the treatment of primary immunodeficiency (PI). Gamunex-C was previously approved for intravenous administration for the treatment of PI, chronic inflammatory demyelinating polyneuropathy, and idiopathic thrombocytopenic purpura (ITP). Gamunex-C should not be used subcutaneously in patients with ITP, due to risk of hematoma.

Dosage Form: Single-use bottles: 1 g/10 mL, 2.5 g/25 mL, 5 g/50 mL, 10 g/100 mL, or 20 g/200 mL

For More Information: www.talecris.com

Prism Pharmaceuticals Inc (King of Prussia, PA)

Indication: The FDA approved the supplemental new drug application for Nexterone (amiodarone hydrochloride) Premixed Injection. Nexterone is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. It is the first and only premixed intravenous (IV) bag formulation of the antiarrhythmic agent amiodarone IV.

Dosage Form: 1.5 mg/mL for rapid loading infusion, and 1.8 mg/mL for subsequent infusion

For More Information: www.prismpharma.com

Pfizer Inc (New York, NY)

Indication: The FDA approved the supplemental new drug application for Revatio (sildenafil) Tablets and Injection. Revatio is a phosphodiesterase-5 inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH; World Health Organization Group I) to improve exercise ability and delay clinical worsening. Studies establishing effectiveness included predominately patients with New York Heart Association Functional Class II to III symptoms and etiologies of primary pulmonary hypertension or pulmonary hypertension associated with connective tissue disease. In pulmonary hypertension secondary to sickle cell disease, Revatio may cause serious vaso-occulusive crises.

Dosage Form: Injection: 10 mg (12.5 mL) single-use vial; Tablets: 20 mg

For More Information: www.revatio.com