Rx Product News

Pharmacy Times, Volume 0,0

Trilipix

Marketed by:

Abbott Laboratories (Abbott Park, IL)

Indication:

December 15, 2008—TheFDA approved Abbott'sTrilipix (fenofibric acid)delayed-release capsules for use along with diet tohelp lower triglycerides and low-density lipoproteincholesterol, and to raise high-density lipoproteincholesterol in patients with lipid problems. It is aperoxisome proliferator receptor alpha and is thefirst and only fibrate to be approved for use in combinationwith a statin. Trilipix has not been shown toprevent heart disease or heart attack.

Dosage Form:

Capsules: 45 and 135 mg

For More Information:

www.trilipix.com

800-633-9110

Epiduo Gel

Marketed by:

Galderma Laboratories LP (Fort Worth, TX)

Indication:

January 6, 2009—Galderma Laboratories announcedthe availability of Epiduo (adapalene and benzoyl peroxide)Gel 0.1%/2.5%. This product represents thefirst and only, once-daily, topical acne treatment thatcombines the well-tolerated retinoid adapalene andbenzoyl peroxide, an antimicrobial with no evidence ofpromoting bacterial resistance. Epiduo Gel is indicatedfor the topical treatment of acne vulgaris in patients 12years of age and older. Patients should apply the gelin a thin film to affected areas of the face and/or trunkonce daily after washing; patients should use a peasizedamount for each area of the face (eg, forehead,chin, each cheek). The eyes, lips, and mucous membranesshould be avoided during application.

Dosage Form:

Each gram of Epiduo Gel contains 1 mg (0.1%) adapaleneand 25 mg (2.5%) benzoyl peroxide in anaqueous-based gel.

For More Information:

www.galdermaUSA.com

Latisse

Marketed by:

Allergan Inc (Irvine, CA)

Indication:

December 26,2008—Allergan Incannounced FDAapproval of Latisse(bimatoprost ophthalmicsolution) 0.03%as a novel treatment for hypotrichosis of the eyelashes(having inadequate or not enough eyelashes).Latisse is the first and only science-based treatmentapproved by the FDA to enhance eyelash prominenceas measured by increases in length, thickness,and darkness of eyelashes. Bimatoprost, the activepharmaceutical ingredient in Latisse, is a structuralprostaglandin analog—a lipid compound derived fromfatty acids designed to bind to prostaglandin receptors.The solution is intended for use on the skin ofthe upper eyelid margins at the base of the eyelashes(not the lower eyelid).

Dosage Form:

Bimatoprost ophthalmic solution 0.3 mg/mL

For More Information:

www.latisse.com

Norditropin

Marketed by:

Novo Nordisk Inc (Princeton, NJ)

Indication:

November 4, 2008—The FDA approved anadditional indication for Norditropin (somatropin[rDNA origin] injection) for the treatment ofshort stature in children born small for gestationalage with no catch-up growth by 2 to 4years of age. Children born with this conditionnow have a new treatment option to help themgrow to a normal height. It also is indicated forthe treatment of children with short statureassociated with Noonan syndrome, treatmentof children with short stature associated withTurner syndrome, and treatment of childrenwith growth failure due to inadequate secretionof endogenous growth hormone. Norditropinalso is indicated for replacement of endogenousgrowth hormone in adults with either adult- orchildhood-onset growth hormone deficiency.

Dosage Form:

Cartridges are available for use with the correspondingNordiPens or preloaded in the NorditropinNordiFlex pens—5 mg/1.5 mL: cartridge andNorditropin NordiFlex pen; 10 mg/1.5 mL: NorditropinNordiFlex pen only; 15 mg/1.5 mL: cartridge andNorditropin NordiFlex pen.

For More Information:

www.novonordisk-us.com

Moxatag

Marketed by:

MiddleBrook Pharmaceuticals Inc(Westlake, TX)

Indication:

January 7, 2009—MiddleBrookPharmaceuticals Inc announcedthat the launch of Moxatag (amoxicillinextended-release) Tablets,775 mg, will begin in March. Moxatag is the first andonly once-a-day amoxicillin product indicated for thetreatment of tonsillitis and/or pharyngitis secondaryto Streptococcus pyogenes in adults and pediatricpatients aged 12 years or older. The formulationof Moxatag consists of 1 immediate-release and 2delayed-release components of amoxicillin. These3 components are combined in a specific ratio toprolong the release of amoxicillin from Moxatag,compared with currently available immediate-releaseamoxicillins.

Dosage Form:

Tablets: 775 mg

For More Information:

www.middlebrookpharma.com

PreNexa

Marketed by:

Upsher-Smith Laboratories Inc (Minneapolis, MN)

Indication:

December 3,2008—Upsher-SmithLaboratories announcedits plans to marketPreNexa, the first and only single-gel capsule prenatalvitamin with the most plant-based docosahexanoicacid (DHA, 265 mg) for women considering pregnancy,pregnant women, and mothers who are breastfeeding.PreNexa is a once-daily single-gel capsuleindicated to provide vitamin/mineral and plant-basedDHA supplementation throughout pregnancy, duringthe postnatal period for both lactating and nonlactatingmothers, and throughout the childbearing years.

Dosage Form:

One soft gel capsule daily or as directed by a physician

For More Information:

www.prenexa.com

Prezista

Marketed by:

Tibotec Therapeutics/Division ofOrtho Biotech Products, LP(Bridgewater, NJ)

Indication:

November 19, 2008—TibotecTherapeutics announced thelaunch of a 400-mg Prezista (darunavir)tablet. Prezista is a proteaseinhibitor indicated for thetreatment of HIV infection in adult patients. Prezistaalso is indicated for the treatment of HIV infectionin pediatric patients 6 years of age and older. Theproduct must be coadministered with ritonavir andwith other antiretroviral agents. In addition, the FDArecently granted approval for an expanded indicationfor Prezista once-daily dosing as part of an HIV combinationtherapy in treatment-na?ve adults.

Dosage Form:

Tablets: 75, 300, 400, and 600 mg

For More Information:

www.prezista.com

877-REACH-TT (877-732-2488)

Zolpimist

Marketed by:

NovaDel Pharma Inc(Flemington, NJ)

Indication:

December 22, 2008—NovaDel Pharma Inc announcedthat Zolpimist (zolpidem tartrate) 5 mg and 10 mgOral Spray was approved by the FDA for the shorttermtreatment of insomnia characterized by difficultieswith sleep initiation. Zolpimist contains zolpidemtartrate, the same active ingredient as Ambien. Dueto its rapid onset of action, patients should takeZolpimist immediately before bedtime and be preparedto get a full night's sleep (7-8 hours).

Dosage Form:

Oral spray: 5 and 10 mg

For More Information:

www.novadel.com

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