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Published Online: Friday, August 1, 2008

Aciphex

Marketed by:

Eisai Corp of North America (Woodcliff Lake, NJ), a wholly owned subsidiary of Eisai Co Ltd (Tokyo, Japan), and PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals Inc (Raritan, NJ)

Indication:

June 30, 2008—Eisai Corp announced that the FDA approved Aciphex (rabeprazole sodium) 20 mg for the short-term (up to 8 weeks) treatment of gastroesophageal reflux disease (GERD) in adolescents aged 12 and older. Aciphex is a proton pump inhibitor that effectively suppresses gastric acid secretion while inhibiting enzyme activity during the last phase of stomach acid secretion. The product also is indicated in adults for healing of erosive or ulcerative GERD; maintenance of healing of erosive or ulcerative GERD; treatment of symptomatic GERD; healing of duodenal ulcers; Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence; and treatment of pathologic hypersecretory conditions, including Zollinger-Ellison syndrome.

Dosage Form:

Tablets: 20 mg

For More Information:

www.aciphex.com




Aptivus

Marketed by:

Boehringer Ingelheim Pharmaceuticals Inc (Ridgefield, CT)

Indication:

June 24, 2008—Boehringer Ingelheim announced that the FDA granted approval of Aptivus (tipranavir) capsules/oral solution with dosing information for treatment-experienced pediatric patients between the ages of 2 and 18 infected with HIV-1. The oral solution formulation, which is a new dosage form of Aptivus, was also approved for treatment-experienced adults. Aptivus, a protease inhibitor coadministered with ritonavir, is indicated for combination antiretroviral treatment of HIV-1?infected patients who are treatment experienced and infected with HIV-1 strains resistant to more than 1 protease inhibitor. The Aptivus dosing for adult patients is 500 mg coadministered with 200 mg ritonavir, twice daily, with or without food; in pediatric patients (aged 2-18 years), the dosing is based on body weight or body surface area, not to exceed adult dose.

Dosage Form:

Capsules: 250 mg
Oral solution: 100 mg/mL

For More Information:

www.aptivus.com




Concerta

Marketed by:

McNeil Pediatrics, a division of Ortho-McNeil-Janssen Inc (Titusville, NJ)

Indication:

June 27, 2008—The FDA approved Concerta (methylphenidate HCl) extended-release tablets for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults aged 18 to 65 years. With this new approval, Concerta is now available for patients with ADHD aged 6 to 65. The doses approved for adults range from 18 to 72 mg daily. Using its unique OROS delivery system, the Concerta formulation delivers an initial dose of medication when the tablet is ingested. Medication is then delivered into the bloodstream at a controlled rate throughout the day.

Dosage Form:

Tablets: 18, 27, 36, and 54 mg

For More Information:

www.concerta.net




Kinrix

Marketed by:

GlaxoSmithKline (Research Triangle Park, NC)

Indication:

June 24, 2008—GlaxoSmithKline announced that the FDA approved Kinrix (diphtheria and tetanus toxoids and acellular pertussis [DTaP] adsorbed and inactivated poliovirus vaccine), the first combination vaccine to offer protection against diphtheria, tetanus, pertussis (also known as whooping cough), and polio diseases in 1 shot. Kinrix is approved for children 4 to 6 years of age whose previous DTaP vaccinations have been with Pediarix and/or Infanrix. Per the Centers for Disease Control and Prevention's recommended immunization schedule, 4- to 6-yearolds can receive 5 or more vaccinations in a single visit. The introduction of Kinrix could mean 1 less shot for children in this age group.

Dosage Form:

Single-dose vial and prefilled syringe containing a 0.5-mL suspension for injection of diphtheria and tetanus toxoids, acellular pertussis antigens, and inactivated poliovirus types 1, 2, and 3.

For More Information:

www.kinrix.com



Hot Rx

Cymbalta

Marketed by:

Eli Lilly and Co (Indianapolis, IN)

Indication:

June 16, 2008—The FDA approved Cymbalta (duloxetine HCl) for the management of fibromyalgia, a chronic widespread pain disorder. Cymbalta is the first serotonin-norepinephrine reuptake inhibitor with proven efficacy for reducing pain in patients with fibromyalgia. This new fibromyalgia indication represents the second use for Cymbalta for a pain disorder approved by the FDA, demonstrating the medication's analgesic effect. Cymbalta also is approved to treat major depressive disorder and generalized anxiety disorder and to manage diabetic peripheral neuropathic pain in adults aged 18 years and older. Based on preclinical studies, Cymbalta is a balanced and potent reuptake inhibitor of serotonin and norepinephrine (which are believed to mediate core mood symptoms and help regulate the perception of pain).

Dosage Form:

Capsules: 20, 30, and 60 mg

For More Information:
www.cymbalta.com



Prezista

Marketed by:

Tibotec Therapeutics, a division of Ortho Biotech Products LP (Bridgewater, NJ)

Indication:

May 19, 2008—Tibotec Therapeutics announced the availability of a new 600-mg tablet strength for Prezista (darunavir), a protease inhibitor. The new dosage strength was approved by the FDA on February 25, 2008. The recommended oral dose of Prezista for treatment-experienced adult patients with HIV-1 is 600 mg (one 600-mg tablet or two 300- mg tablets) taken twice daily with ritonavir 100 mg, in combination with other antiretroviral agents, and with food.

Dosage Form:

Tablets: 300 and 600 mg

For More Information:

www.prezista.com




Trivaris

Marketed by:

Allergan Inc (Irvine, CA)

Indication:

June 16, 2008—Allergan Inc announced that the FDA approved Trivaris (triamcinolone acetonide injectable suspension) 80 mg/mL, a synthetic glucocorticoid corticosteroid with anti-inflammatory action. Delivered via intravitreal injection, the ophthalmic indications for Trivaris include sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids—inflammatory conditions that can result in vision loss.

Dosage Form:

Single-use syringe containing 8 mg (80 mg/mL) of triamcinolone acetonide suspension

For More Information:

www.allergan.com




Xyntha

Marketed by:

Wyeth Pharmaceuticals, a division of Wyeth (Collegeville, PA)

Indication:

February 21, 2008—Wyeth Pharmaceuticals announced that it received approval from the FDA for Xyntha (antihemophilic factor [recombinant], plasma/albumin-free), a recombinant factor VIII product, for patients with hemophilia A for both the control and prevention of bleeding episodes and surgical prophylaxis. Xyntha is manufactured using a completely albumin-free process and state-of-theart nanofiltration purification technology. In addition, Xyntha is the only recombinant factor VIII product to use an entirely synthetic (nonhuman- and nonanimalbased) purification process in its manufacture.

Dosage Form:

Powder available as 250, 500, 1000, or 2000 IU in single-use vials

For More Information:

www.wyeth.com




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