Rx Product News

Folotyn

Marketed by:

Allos Therapeutics Inc (Westminster, CO)

Indication:

Allos Therapeutics recently announced FDA accelerated approval for Folotyn (pralatrexate injection) as a single-agent treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Approval of the application was based on data from the PROPEL trial—an open-label, single-arm, multicenter, international trial that enrolled 115 patients. Data showed a positive overall response rate; however, improvement in progression-free survival and overall survival have not been demonstrated.

Dosage Form:

Sterile, single-use vials containing pralatrexate at a concentration of 20 mg/mL in the following presentations: 20-mg vial of pralatrexate in 1-mL solution (20 mg/1 mL); 40-mg vial of pralatrexate in 2-mL solution (40 mg/2 mL)

For More Information:

www.allos.com

Eraxis

Marketed by:

Pfizer Inc (New York, NY)

Indication:

The FDA approved a new preparation for Eraxis (anidulafungin) for injection—it is now available for reconstitution with sterile water for injection. Eraxis is indicated for use in the treatment of Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis), as well as esophageal candidiasis. Candidemia is a serious fungal infection caused by certain species of Candida, a yeast commonly found on the skin, in the digestive tract, or as a contaminant on medical equipment and devices, and is the most deadly of the common hospital-acquired bloodstream infections. Eraxis now offers health care professionals the opportunity to avoid the use of ethanol as a solvent.

Dosage Form:

Single-use vials: 50 and 100 mg

For More Information:

www.eraxisrx.com

Cymbalta

Marketed by:

Eli Lilly and Co (Indianapolis, IN)

Indication:

The FDA recently approved Cymbalta (duloxetine HCl) for the maintenance treatment of generalized anxiety disorder (GAD) in adults. This new indication represents the sixth approval for Cymbalta—the product is also approved for the acute and maintenance treatment of major depressive disorder and to manage diabetic peripheral neuropathic pain and fibromyalgia. GAD affects nearly 7 million Americans at any given time. Symptoms of GAD may include excessive worry or anxiety over a period of 6 months or longer, difficulties controlling worry, irritability, poor concentration, sleep disturbances, fatigue, restlessness, and muscle tension; symptoms can vary from individual to individual.

Dosage Form:

Capsules: 20, 30, and 60 mg

For More Information:

www.cymbalta.com

Geodon

Marketed by:

Pfizer Inc (New York, NY)

Indication:

Pfizer recently announced that the FDA approved Geodon (ziprasidone HCl) Capsules for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. The approval is based on clinical data demonstrating that Geodon is an effective and generally well-tolerated adjunctive treatment for long-term symptom control in patients with bipolar disorder. Geodon, an atypical antipsychotic, in oral formulation, is also indicated for the treatment of schizophrenia and the acute treatment as monotherapy of manic or mixed episodes associated with bipolar I disorder. As an intramuscular injection, Geodon is indicated for the acute treatment of agitation in schizophrenic patients.

Dosage Form:

Capsules: 20, 40, 60, and 80 mg Intramuscular injection: 20-mg/mL single-use vials

For More Information:

www.geodon.com

Lusedra

Marketed by:

Eisai Inc (Woodcliff Lake, NJ)

Indication:

Eisai Inc lately announced that Lusedra (fospropofol disodium) Injection is now available for use by individuals trained in the administration of general anesthesia. Lusedra is an intravenous sedativehypnotic agent indicated for monitored anesthesia care sedation in adult patients undergoing diagnostic or therapeutic procedures. With this availability, patients undergoing sedation have a new option. Lusedra is designated as a Schedule IV drug.

Dosage Form:

Injection, solution containing 1050 mg fospropofol disodium per 30 mL

For More Information:

www.eisai.com/product.asp?ID=274

Micardis

Marketed by:

Boehringer Ingelheim Pharmaceuticals Inc (Ridgefield, CT)

Indication:

Boehringer Ingelheim Pharmaceuticals Inc announced that the FDA approved a new indication for Micardis (telmisartan) Tablets 80 mg for the reduction of risk of myocardial infarction, stroke, or death from cardiovascular (CV) causes in patients aged 55 years or older at high risk of developing major CV events who are unable to take angiotensin-converting enzyme inhibitors. Micardis is the first treatment in its class to be approved for this indication. Micardis, an angiotensin II receptor blocker, is also approved for the treatment of hypertension— it may be used alone or in combination with other antihypertensive agents.

Dosage Form:

Tablets: 20, 40, and 80 mg

For More Information:

www.mymicardis.com

Qutenza

Marketed by:

NeurogesX Inc (San Mateo, CA)

Indication:

NeurogesX Inc announced recently that the FDA approved Qutenza (capsaicin) 8% patch, the first and only product containing prescription-strength capsaicin (the “hot” ingredient found in chili peppers), for the management of neuropathic pain due to postherpetic neuralgia, the nerve pain that can follow shingles. After a single 1-hour application by a physician or a health care professional, in which the patch is placed directly on the site of the pain, Qutenza can reduce post-shingles—related pain for 12 weeks.

Dosage Form:

Qutenza patch contains 8% capsaicin (640 mcg/cm2). Each patch contains a total of 179 mg of capsaicin.

For More Information:

www.qutenza.com

Marketed by:

Eli Lilly and Co (Indianapolis, IN)

Indication:

The FDA approved Zyprexa (olanzapine) in tablet form for 2 adolescent indications— as an option for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder in adolescents aged 13 to 17 years. The updated label states that clinicians should take into consideration the increased potential for weight gain and hyperlipidemia in adolescents, compared with adults, and the potential for long-term risks, which in many cases, may lead them to consider prescribing other drugs first in adolescents. The recommended starting dose for adolescents is lower than that for adults.

Dosage Form:

Tablets: 2.5, 5, 7.5, 10, 15, 20 mg Orally disintegrating tablets: 5, 10, 15, 20 mg Intramuscular injection: 10-mg vial

For More Information:

www.zyprexa.com â–