New Product Newswire

November 21, 2005

San-Diego-based PrimaPharm Inc., (858) 259-0107, has gained approval for Hydase (hyaluronidase injection) as an adjuvant to increase the absorption and dispersion of other drugs, for hypodermoclysis, and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. Hyaluronidase was not available in the United States for several years. It was most commonly used in combination with local anesthetics in ophthalmic surgery.

NEW DRUGS

San-Diego-based PrimaPharm Inc., (858) 259-0107, has gained approval for Hydase (hyaluronidase injection) as an adjuvant to increase the absorption and dispersion of other drugs, for hypodermoclysis, and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. Hyaluronidase was not available in the United States for several years. It was most commonly used in combination with local anesthetics in ophthalmic surgery.

PharmaDerm, Atlanta, (678) 287-1500, is officially launchinhtdg Cutivate (fluticasone propionate) Lotion, 0.05%. The mid-potency steroid lotion is approved for patients one year of age and older for the treatment of atopic dermatitis with once-a-day dosing. The product is available in a 60-mL bottle.

A newly approved diabetes treatment for children provides duration of action of up to 24 hours. Levemir (insulin detemir [rDNA origin] injection) is a long-acting basal insulin analogue found to be safe and effective for controlling hyperglycemia in children with Type 1 diabetes mellitus. The maker is Novo Nordisk, Princeton, N.J., (800) 727-6500.

NEW INDICATIONS

Trileptal (oxcarbazepine), in tablets and oral suspension, has been granted an expanded indication. From Novartis Pharmaceuticals, East Hanover, N.J., (862) 778-8300, the medication can now be used as adjunctive therapy in the treatment of partial seizures in children aged two to four years with epilepsy.

Allegra (fexofenadine hydrochloride), a product of Sanofi-Aventis, Bridgewater, N.J., (908) 243-6000, has FDA approval for once-daily use of 180-mg tablets in the treatment of adults and children 12 years of age and older for chronic idiopathic urticaria. This approval provides for a decrease in the frequency of administration of the drug. The 60-mg tablet was approved earlier for twice-daily use for this indication in this population group.

Havrix (hepatitis A vaccine, inactivated), from GlaxoSmithKline, Philadelphia, (888) 825-5249, has been granted an expanded indication for the prevention of hepatitis A in children 12 months of age and older. The drug was approved earlier for use in children aged two through 18.

Luitpold Pharmaceuticals, Shirley, N.Y., (800) 645-1706, has received approval for Venofer (iron sucrose injection, USP) for the treatment of iron deficiency anemia in peritoneal dialysis-dependent chronic kidney disease patients receiving erythropoietin. The drug was initially approved in 2000 for treating iron deficiency anemia in patients undergoing hemodialysis on supplemental erythropoietin therapy.

NEW FORMULATIONS

For Pharmacia & Upjohn, New York City, (800) 533-4535, the FDA has approved Niravam (alprazolam orally disintegrating tablets) for the treatment of anxiety disorders. According to Pharmacia, the drug works the same as Xanax (also alprazolam) but uses RapiTab technology to create an orally disintegrating formula that can be administered with or without water.

NEW DOSAGE STRENGTHS

Merck & Co., Whitehouse Station, N.J., (908) 423-1000, is introducing Hyzaar tablets, in 100/12.5-mg dosage strength, combining the once-daily efficacy of 100-mg Cozaar (losartan potassium) with a low-dose diuretic to offer another losartan titration option. Hyzaar is indicated to treat hypertension and to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy.

NEW DELIVERY

NovoLog, (insulin aspart [rDNA origin]), from Novo Nordisk, previously approved for subcutaneous injection for glycemic control in patients with diabetes mellitus, now has clearance for in-travenous administration-under proper medical supervision in a clinical setting.