Rx Product News

MARCH 01, 2007

Lialda (mesalamine)

Marketed by: Shire plc (Philadelphia, Pa)

Indication: January 16, 2007?Lialda, the first and only oral once-daily mesalamine for colitis patients, was approved by the FDA, according to Shire plc. Lialda with MMX technology is indicated for the induction of remission in patients with active, mild-to-moderate ulcerative colitis. In the drug class called aminosalicylates, Lialda contains the highest mesalamine dose per tablet, so patients can take as few as 2 tablets a day; this helps increase adherence, as many other available medications require dosing 3 to 4 times daily and 6 to 16 pills per day, and a recent study showed pill burden to be a cause of poor adherence.

Dosage form: Tablets: 1.2 g

For more information: www.lialda.com

MetroGel (metronidazole) Topical Gel 1%

Marketed by: Galderma Laboratories LP (Fort Worth, Tex)

Indication: January 12, 2007?Galderma Laboratories announced the availability of a new MetroGel 1% Kit for the treatment of inflammatory lesions of rosacea. The kit contains a 60-g tube of the leading topical prescription treatment for rosacea, MetroGel (metronidazole) topical gel, 1%. MetroGel 1% uses a vehicle containing HSA-3, a combination of niacinamide, betadex, and propylene glycol. The vehicle is a water-based formulation and contains no alcohol. As opposed to the twice-a-day dosing of most other rosacea treatments, the product requires only once-a-day dosing.

Dosage form: 60-g tube

For more information: www.metrogel.com 866-735-4137

NovoLog (Insulin Aspart [rDNA Origin] Injection)

Marketed by: Novo Nordisk (Princeton, NJ)

Indication: January 30, 2007?Novo Nordisk announced that the FDA approved NovoLog, a rapid-acting form of insulin for patients with diabetes for the control of hyperglycemia, for pregnancy Category B rating, further validating NovoLog as a safe and effective treatment for pregnant women with type 1 diabetes and their unborn children. It was previously classified with a Category C rating?indicating that adverse effects on the fetus have been demonstrated in animal-reproduction studies, and that adequate and well-controlled studies in pregnant women have not been conducted to demonstrate safety. Following the review of the largest randomized controlled trial of insulin analogs in pregnant women, the FDA approved NovoLog for Category B rating, which indicates that adequate studies in pregnant women with type 1 diabetes have demonstrated that NovoLog does not increase risk to the unborn baby.

Dosage form: 10-mL vials; 3-mL PenFill cartridges; 3-mL NovoLog FlexPen prefilled syringe (each package size contains 100 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 Laboratories announced FDA approval of Olux-E Foam, 0.05%. Olux-E is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, also known as psoriasis and eczema, in patients aged 12 years or older. It has been shown to suppress the hypothalamic-pituitary-adrenal axis. The VersaFoam vehicle is a unique, patented, and versatile 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.com www.stiefel.com


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

Indication: January 24, 2007?Zylera Pharmaceuticals announced the availability of Relamine (chondroitin 300 mg, glucosamine 400 mg, and primorine 425 mg), a novel prescription treatment for osteoarthritis (OA). Relamine is the first and only prescription product that contains pharmaceutical-quality chondroitin, glucosamine, and primorine. The product helps to reduce the joint inflammation of OA and control pain and may slow the onset and progression of 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?Everett Laboratories introduced Vitafol-OB+DHA (docosahexaenoic acid), a prenatal vitamin/mineral combination. These caplets contain 15 essential vitamins and minerals and come with a separate plant-based DHA capsule for use before, during, and after pregnancy. The product is a small, easy-to-swallow prenatal combination and is supplied in a unit-dose package so that the patient will know to take 1 blue Vitafol-OB caplet and 1 liquidfilled DHA capsule daily. Increased availability of DHA during pregnancy and lactation nourishes the neurologic, visual, and nervous system development of babies and may have long-term implications in infant heart health and maternal well-being.

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

For more information: www.everettlabs.com

Vortex Non Electrostatic Valved Holding Chamber

Marketed by: Pari Respiratory Equipment Inc (Midlothian, Va)

Indication: Pari Respiratory Equipment recently introduced the Vortex, the first nonelectrostatic valved holding chamber in North America. The nonelectrostatic charge of the Vortex ensures that patients receive a more consistent medication dose. It also features a cyclonic inspiratory flow pattern, which further enhances aerosol delivery for patients with low tidal volume. With this pattern, more aerosol particles stay in suspension and are available for inhalation. The Vortex is available in 5 different versions: Baby Whirl duckling mask (for toddlers aged 1-2 years); Spinner duck mask (for children aged 3 years and up); valved holding chamber; adult mask; and hospital package.

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


Marketed by: Takeda Pharmaceuticals North America Inc (Deerfield, Ill)

Indication: November 7, 2006?Duetact (pioglitazone HCl and glimepiride) was made available by prescription across the United States for the treatment of type 2 diabetes, according to Takeda Pharmaceuticals North America Inc. In a single tablet, Duetact combines 2 diabetes medications?pioglitazone HCl (Actos) and glimepiride?which have complementary actions and work together to help achieve and sustain blood glucose management in patients with type 2 diabetes. Actos directly targets insulin resistance, and glimepiride, a sulfonylurea, acts primarily by increasing the amount of insulin produced by the pancreas.

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

For more information: www.tpna.com