Rx Product News

Pharmacy Times, Volume 0, 0

Lialda (mesalamine)

Marketed by:Shire plc(Philadelphia, Pa)

Indication:January 16, 2007?Lialda, the first and onlyoral once-daily mesalamine for colitis patients, wasapproved by the FDA, according to Shire plc. Lialdawith MMX technology is indicated for the inductionof remission in patients with active, mild-to-moderateulcerative colitis. In the drug class calledaminosalicylates, Lialda contains the highestmesalamine dose per tablet, so patients can takeas few as 2 tablets a day; this helps increase adherence,as many other available medications requiredosing 3 to 4 times daily and 6 to 16 pills per day,and a recent study showed pill burden to be acause of poor adherence.

Dosage form:Tablets: 1.2 g

For more information:www.lialda.com

MetroGel (metronidazole) Topical Gel 1%

Marketed by:Galderma LaboratoriesLP (Fort Worth, Tex)

Indication:January 12, 2007?Galderma Laboratoriesannounced the availabilityof a newMetroGel 1% Kit for thetreatment of inflammatorylesions of rosacea.The kit contains a 60-gtube of the leading topicalprescription treatment for rosacea, MetroGel(metronidazole) topical gel, 1%. MetroGel 1% uses avehicle containing HSA-3, a combination of niacinamide,betadex, and propylene glycol. The vehicleis a water-based formulation and contains no alcohol.As opposed to the twice-a-day dosing of mostother rosacea treatments, the product requires onlyonce-a-daydosing.

Dosage form:60-g tube

For more information:www.metrogel.com866-735-4137

NovoLog (Insulin Aspart [rDNA Origin] Injection)

Marketed by:Novo Nordisk(Princeton, NJ)

Indication:January 30, 2007?Novo Nordisk announced thatthe FDA approved NovoLog, a rapid-acting form ofinsulin for patients with diabetes for the control ofhyperglycemia, for pregnancy Category B rating,further validating NovoLog as a safe and effectivetreatment for pregnant women with type 1 diabetesand their unborn children. It was previouslyclassified with a Category C rating?indicating thatadverse effects on the fetus have been demonstratedin animal-reproduction studies, and thatadequate and well-controlled studies in pregnantwomen have not been conducted to demonstratesafety. Following the review of the largest randomizedcontrolled trial of insulin analogs in pregnantwomen, the FDA approved NovoLog for Category Brating, which indicates that adequate studies inpregnant women with type 1 diabetes have demonstratedthat NovoLog does not increase risk to theunborn baby.

Dosage form:10-mL vials; 3-mL PenFill cartridges; 3-mL NovoLogFlexPen prefilled syringe (each package size contains100 units of insulin aspart per mL)

For more information:www.novonordisk-us.com

Olux-E (clobetasol propionate) Foam, 0.05%

Marketed by:Stiefel Laboratories Inc(Coral Gables, Fla)

Indication:January 23, 2007?Stiefel Laboratoriesannounced FDAapproval of Olux-E Foam, 0.05%.Olux-E is indicated for the treatmentof inflammatory and pruriticmanifestations of corticosteroid-responsive dermatoses,also known as psoriasis and eczema, inpatients aged 12 years or older. It has been shownto suppress the hypothalamic-pituitary-adrenal axis.The VersaFoam vehicle is a unique, patented, andversatile foam formulation for delivering medication,such as corticosteroids and antibiotics, into the skin.

Dosage form:50-and 100-g canisters

For more information:www.olux-e.comwww.stiefel.com

Relamine

Marketed by:Zylera Pharmaceuticals, a whollyowned subsidiary of TRx Pharma(Research Triangle Park, NC)

Indication:January 24, 2007?ZyleraPharmaceuticals announced theavailability of Relamine (chondroitin300 mg, glucosamine 400mg, and primorine 425 mg), anovel prescription treatment forosteoarthritis (OA). Relamine isthe first and only prescriptionproduct that contains pharmaceutical-qualitychondroitin, glucosamine, and primorine. The producthelps to reduce the joint inflammation of OAand control pain and may slow the onset and progressionof OA.

Dosage form:2 tablets twice daily

For more information:www.zylera.com

Vitafol-OB+DHA Caplets

Marketed by:Everett Laboratories Inc(West Orange, NJ)

Indication:February 2007?EverettLaboratories introducedVitafol-OB+DHA (docosahexaenoicacid), a prenatalvitamin/mineral combination. These caplets contain15 essential vitamins and minerals and come with aseparate plant-based DHA capsule for use before,during, and after pregnancy. The product is a small,easy-to-swallow prenatal combination and is suppliedin a unit-dose package so that the patient willknow to take 1 blue Vitafol-OB caplet and 1 liquidfilledDHA capsule daily. Increased availability ofDHA during pregnancy and lactation nourishes theneurologic, visual, and nervous system developmentof babies and may have long-term implicationsin infant heart health and maternal well-being.

Dosage form:Caplets: 2700 IU vitamin A; 400 IU vitamin D; 70 mgvitamin C; 30 IU vitamin E; 1 mg folic acid; 1.6 mgvitamin B1; 1.8 mg vitamin B2; 2.5 mg vitamin B6; 12mcg vitamin B12; 18 mg niacin; 100 mg calcium; 65mg elemental iron; 25 mg magnesium; 25 mg zinc;2 mg copperCapsules: 250 mg DHA

For more information:www.everettlabs.com

Vortex Non Electrostatic Valved Holding Chamber

Marketed by:Pari RespiratoryEquipment Inc(Midlothian, Va)

Indication:Pari RespiratoryEquipment recently introduced theVortex, the first nonelectrostaticvalved holding chamber inNorth America. The nonelectrostatic charge of theVortex ensures that patients receive a more consistentmedication dose. It also features a cyclonicinspiratory flow pattern, which further enhancesaerosol delivery for patients with low tidal volume.With this pattern, more aerosol particles stay insuspension and are available for inhalation. TheVortex is available in 5 different versions: BabyWhirl duckling mask (for toddlers aged 1-2 years);Spinner duck mask (for children aged 3 years andup); valved holding chamber; adult mask; and hospitalpackage.

For more information:www.pari.com800-FAST-NEB (800-327-8632)

Duetact

Marketed by:Takeda PharmaceuticalsNorth America Inc(Deerfield, Ill)

Indication:November 7, 2006?Duetact (pioglitazone HCl andglimepiride) was made available by prescriptionacross the United States for the treatment of type2 diabetes, according to Takeda PharmaceuticalsNorth America Inc. In a single tablet, Duetactcombines 2 diabetes medications?pioglitazoneHCl (Actos) and glimepiride?which have complementaryactions and work together to helpachieve and sustain blood glucose managementin patients with type 2 diabetes. Actos directlytargets insulin resistance, and glimepiride, a sulfonylurea,acts primarily by increasing the amountof insulin produced by the pancreas.

Dosage form:Tablets: 30 mg/2 mg and 30 mg/4 mg

For more information:www.tpna.com