rx PRODUCT news

Calafol Rx

Marketed by:

Alaven Pharmaceutical LLC (Marietta, Ga)

Indication:

Alaven Pharmaceutical LLC recently launched Calafol Rx, which is indicated for the distinctive nutritional requirements of individuals under a physician's treatment with or at risk for cardiovascular disease, cerebrovascular disease, osteoporosis, micronutrient deficiencies associated with inflammatory bowel disease, and dementia, with particular emphasis on menopausal patients (including those patients treated with or eligible for hormone replacement therapies), patients with uterine fibroids, and patients with endometriosis. Calafol Rx is a micronutrient supplement for patients on bisphosphonates or long-term proton pump inhibitor therapy and helps reduce bone loss and the levels of plasma homocysteine associated with cardiovascular disease, while helping to promote muscle strength and overall bone health. Each oval white coated tablet contains 1.6 mg folacin (as folic acid USP), 425 mcg hydroxocobalamin (vitamin B _12a), 25 mg pyridoxine (vitamin B ₆), 600 mg calcium (as calcium carbonate), 400 IU cholecalciferol (vitamin D ₃), and 5 mg policosanol.

Dosage form:

1 tablet once or twice daily, with food

For more information:

www.calafolrx.com, www.alavenpharm.com 888-317-0001

Elestrin

Marketed by:

Bradley Pharmaceuticals Inc (Fairfield, NJ)

Indication:

June 13, 2007-Bradley Pharmaceuticals Inc announced the launch of Elestrin (estradiol gel 0.06%) by the company's Kenwood Therapeutics Division. Approved by the FDA in December 2006, Elestrin is an effective, low-dose transdermal estrogen therapy indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. Bradley Pharmaceuticals in-licensed the product from BioSante Pharmaceuticals late last year. Elestrin is a colorless, nonstaining, fast-drying gel that is applied once daily over a small area of the upper arm and/or shoulder. The patient should be instructed to prime the pump 10 times prior to the first application and to apply it at the same time each day to clean, dry, unbroken skin.

Dosage form:

Elestrin (estradiol 0.06%) gel is supplied in a nonaerosol, metered-dose pump container; 1 pump provides systemic delivery of 0.0125 mg of estradiol daily

For more information:

www.bradpharm.com

Endometrin

Marketed by:

Ferring Pharmaceuticals (Parsippany, NJ)

Indication:

June 21, 2007- Ferring Pharmaceuticals announced that it received approval from the FDA to market Endometrin (progesterone) Vaginal Insert, 100 mg. Endometrin is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology treatment for infertile women. Progesterone is necessary to increase endometrial receptivity for implantation of an embryo and to support early pregnancy. The insert is to be administered vaginally 2 or 3 times daily, starting at oocyte retrieval and continuing for up to 10 weeks total duration.

Dosage form:

Vaginal insert: 100 mg

For more information:

www.ferringusa.com 888-337-7464

Lovaza

Marketed by:

Reliant Pharmaceuticals Inc (Liberty Corner, NJ)

Indication:

August 3, 2007-Reliant Pharmaceuticals announced that the brand name prescription, Omacor, was changed to Lovaza (omega-3- acid ethyl esters). This change was implemented in response to a limited number of reports of prescribing and dispensing errors due to similarity in name between Omacor capsules and Xanodyne Pharmaceuticals' Amicar (aminocaproic acid). The name change is intended to minimize future errors. Lovaza is indicated as an adjunct to diet to reduce very high (greater than or equal to 500 mg/dL) triglyceride levels in adult patients. In individuals with hypertriglyceridemia, excess body weight and excess alcohol intake may be important contributing factors and should be addressed before initiating any drug therapy.

Dosage form:

Soft-gelatin capsules: 1 g (daily dose is 4 g/day)

For more information:

www.lovaza.com 877-311-7515

Risperdal

Marketed by:

Janssen LP (Titusville, NJ)

Indication:

August 22, 2007-The FDA approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents aged 13 to 17, and for the short-term treatment of bipolar mania associated with manic or mixed episodes of bipolar I disorder in children and adolescents aged 10 to 17. Risperdal is indicated in adults for the treatment of schizophrenia, for the treatment of manic symptoms of acute manic or mixed episodes associated with bipolar I disorder, for the treatment of irritability associated with autistic disorder in patients aged 5 to 16 years, for the treatment of schizophrenia in adolescents aged 13 to 17 years, and for the short-term treatment of bipolar mania associated with bipolar I disorder in children and adolescents aged 10 to 17 years.

Dosage form:

Tablets: 0.25, 0.5, 1, 2, 3, and 4 mg Oral solution: 1 mg/mL Orally disintegrating tablets: 0.5, 1, 2, 3, and 4 mg

For more information:

www.janssen.com

Selzentry Tablets

Marketed by:

Pfizer Inc (New York, NY)

Indication:

August 6, 2007-The FDA approved Selzentry (maraviroc) Tablets, the first in a new class of oral HIV medications in more than 10 years. Selzentry blocks viral entry into white blood cells, significantly reducing viral load and increasing T-cell counts in treatment-experienced patients infected with a specific type of HIV. Selzentry is the first in a class of drugs known as CCR5 antagonists, which block the CCR5 coreceptor, the virus' predominant entry route into T cells. Selzentry stops the R5 virus on the outside surface of the cells before it enters, rather than fighting the virus inside, as do all other classes of oral HIV medicines.

Dosage form:

Tablets: 150 and 300 mg

For more information:

www.pfizer.com

Lipofen

Marketed by:

ProEthic Pharmaceuticals Inc (Montgomery, Ala)

Indication:

September 7, 2007- ProEthic Pharmaceuticals Inc announced the availability of Lipofen (fenofibrate) in pharmacies by October 1. Lipofen is indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein, total cholesterol, triglycerides, and apolipoprotein B, and to increase highdensity lipoprotein cholesterol in adult patients with primary hypercholesterolemia or mixed dyslipidemia. Lipofen also is indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia. For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of Lipofen is 150 mg per day. For adult patients with hypertriglyceridemia, the initial dose is 50 to 100 mg per day. The maximum dose is 150 mg per day.

Dosage form:

Capsules: 50 and 150 mg

For more information:

www.lipofenrx.com

Nuvigil Tablets

Marketed by:

Cephalon Inc (Frazer, Pa)

Indication:

June 18, 2007-Cephalon Inc announced that it received FDA approval to market Nuvigil (armodafinil) Tablets [C-IV], a nonamphetamine, wake-promoting agent for the treatment of excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy, and shift work sleep disorder. In OSAHS, Nuvigil is indicated as an adjunct to standard treatment(s) for the underlying obstruction. The active pharmaceutical ingredient in Nuvigil, armodafinil, is the longer lived r-enantiomer of modafinil, the active ingredient in Provigil.

Dosage form:

Tablets: 50, 150, and 250 mg

For more information:

www.cephalon.com 800-896-5855