rxPRODUCTnews

Pharmacy Times, Volume 0, 0

Aciphex

Marketed by:

Eisai Corp of North America(Woodcliff Lake, NJ), awholly owned subsidiary ofEisai Co Ltd (Tokyo, Japan),and PriCara, a divisionof Ortho-McNeil-JanssenPharmaceuticals Inc(Raritan, NJ)

Indication:

June 30, 2008—Eisai Corp announced that the FDAapproved Aciphex (rabeprazole sodium) 20 mg forthe short-term (up to 8 weeks) treatment of gastroesophagealreflux disease (GERD) in adolescents aged12 and older. Aciphex is a proton pump inhibitor thateffectively suppresses gastric acid secretion whileinhibiting enzyme activity during the last phase ofstomach acid secretion. The product also is indicatedin adults for healing of erosive or ulcerative GERD;maintenance of healing of erosive or ulcerative GERD;treatment of symptomatic GERD; healing of duodenalulcers; Helicobacter pylori eradication to reducethe risk of duodenal ulcer recurrence; and treatmentof pathologic hypersecretory conditions, includingZollinger-Ellison syndrome.

Dosage Form:

Tablets: 20 mg

For More Information:

www.aciphex.com

Aptivus

Marketed by:

Boehringer IngelheimPharmaceuticals Inc(Ridgefield, CT)

Indication:

June 24, 2008—BoehringerIngelheim announced that theFDA granted approval of Aptivus(tipranavir) capsules/oral solutionwith dosing information fortreatment-experienced pediatricpatients between the ages of 2and 18 infected with HIV-1. The oral solution formulation,which is a new dosage form of Aptivus, was alsoapproved for treatment-experienced adults. Aptivus,a protease inhibitor coadministered with ritonavir,is indicated for combination antiretroviral treatmentof HIV-1?infected patients who are treatment experiencedand infected with HIV-1 strains resistant tomore than 1 protease inhibitor. The Aptivus dosing foradult patients is 500 mg coadministered with 200 mgritonavir, twice daily, with or without food; in pediatricpatients (aged 2-18 years), the dosing is basedon body weight or body surface area, not to exceedadult 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 (methylphenidateHCl) extended-release tablets for thetreatment of attention-deficit/hyperactivity disorder(ADHD) in adults aged 18 to 65 years. With this newapproval, Concerta is now available for patients withADHD aged 6 to 65. The doses approved for adultsrange from 18 to 72 mg daily. Using its unique OROSdelivery system, the Concerta formulation delivers aninitial dose of medication when the tablet is ingested.Medication is then delivered into the bloodstream ata 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 announcedthat the FDA approvedKinrix (diphtheria and tetanustoxoids and acellular pertussis [DTaP] adsorbedand inactivated poliovirus vaccine), the first combinationvaccine to offer protection against diphtheria,tetanus, pertussis (also known as whooping cough),and polio diseases in 1 shot. Kinrix is approved forchildren 4 to 6 years of age whose previous DTaPvaccinations have been with Pediarix and/or Infanrix.Per the Centers for Disease Control and Prevention'srecommended immunization schedule, 4- to 6-yearoldscan receive 5 or more vaccinations in a singlevisit. The introduction of Kinrix could mean 1 less shotfor children in this age group.

Dosage Form:

Single-dose vial and prefilled syringe containing a 0.5-mL suspension for injection of diphtheria and tetanustoxoids, acellular pertussis antigens, and inactivatedpoliovirus 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 FDAapproved Cymbalta (duloxetineHCl) for the managementof fibromyalgia, achronic widespread pain disorder. Cymbalta is thefirst serotonin-norepinephrine reuptake inhibitorwith proven efficacy for reducing pain in patientswith fibromyalgia. This new fibromyalgia indicationrepresents the second use for Cymbalta for apain disorder approved by the FDA, demonstratingthe medication's analgesic effect. Cymbalta also isapproved to treat major depressive disorder andgeneralized anxiety disorder and to manage diabeticperipheral neuropathic pain in adults aged 18 yearsand older. Based on preclinical studies, Cymbaltais a balanced and potent reuptake inhibitor of serotoninand norepinephrine (which are believed tomediate core mood symptoms and help regulatethe perception of pain).

Dosage Form:

Capsules: 20, 30, and 60 mg

For More Information:www.cymbalta.com

Prezista

Marketed by:

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

Indication:

May 19, 2008—TibotecTherapeutics announced the availabilityof a new 600-mg tabletstrength for Prezista (darunavir), a protease inhibitor.The new dosage strength was approved by the FDAon February 25, 2008. The recommended oral doseof Prezista for treatment-experienced adult patientswith HIV-1 is 600 mg (one 600-mg tablet or two 300-mg tablets) taken twice daily with ritonavir 100 mg, incombination with other antiretroviral agents, and withfood.

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 FDAapproved Trivaris (triamcinolone acetonide injectablesuspension) 80 mg/mL, a synthetic glucocorticoid corticosteroidwith anti-inflammatory action. Deliveredvia intravitreal injection, the ophthalmic indicationsfor Trivaris include sympathetic ophthalmia, temporalarteritis, uveitis, and ocular inflammatory conditionsunresponsive to topical corticosteroids—inflammatoryconditions that can result in vision loss.

Dosage Form:

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

For More Information:

www.allergan.com

Xyntha

Marketed by:

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

Indication:

February 21, 2008—Wyeth Pharmaceuticalsannounced that itreceived approval fromthe FDA for Xyntha (antihemophilic factor [recombinant],plasma/albumin-free), a recombinant factorVIII product, for patients with hemophilia A for boththe control and prevention of bleeding episodes andsurgical prophylaxis. Xyntha is manufactured usinga completely albumin-free process and state-of-theartnanofiltration purification technology. In addition,Xyntha is the only recombinant factor VIII product touse an entirely synthetic (nonhuman- and nonanimalbased)purification process in its manufacture.

Dosage Form:

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

For More Information:

www.wyeth.com