New Product Newswire

March 21, 2005

Hyperammonemia, a condition of dangerously heightened levels of ammonia in the bloodstream, can be life-threatening in patients with urea cycle disorder (UCD), an inborn error of urea cycle metabolism. Ammunol, from Medicis Pharmaceutical Corp., Scottsdale, Ariz., (602) 808-8800, combines 10% sodium phenylacetate and 10% sodium benzoate in a new product intended for intravenous hospital use in the event of hyperammonemic crisis. The drug was recently approved for marketing as a "rescue medication."

RxNEW DRUGS Hyperammonemia, a condition of dangerously heightened levels of ammonia in the bloodstream, can be life-threatening in patients with urea cycle disorder (UCD), an inborn error of urea cycle metabolism. Ammunol, from Medicis Pharmaceutical Corp., Scottsdale, Ariz., (602) 808-8800, combines 10% sodium phenylacetate and 10% sodium benzoate in a new product intended for intravenous hospital use in the event of hyperammonemic crisis. The drug was recently approved for marketing as a "rescue medication."

Medicis Pharmaceutical has received FDA approval for Vanos (fluocinonide 0.1% topical cream), a Class I corticosteroid for the treatment of plaque-type psoriasis. The high-potency cream is available in 30- and 60-gm sizes.

People with weakened immune systems or certain skin conditions are susceptible to vaccine complications. A new drug was approved by the FDA as the first intravenous human plasma-derived product available to treat a number of rare complications of smallpox vaccination. Vaccinia Immune Globulin Intravenous (VIGIV) is made from the pooled plasma of donors who receive booster immunizations with the licensed smallpox vaccine Dryvax and is licensed to DynPort Vaccine Co. LLC, Frederick, Md., (301) 607-5000.

NEW FORMULATIONS From Schering-Plough Corp., Kenilworth, N.J., (908) 298-4000, a new nonsedating Clarinex (desloratadine) Syrup (0.5 mg per 1 mL) is now available nationwide. It is indicated for the treatment of indoor allergies and hives in children as young as six months of age and for the relief of outdoor allergy symptoms in children two years of age and older. It is available in bubblegum flavor.

Everett Laboratories, West Orange, N.J., (800) 964-9650, is introducing a chocolate chewable calcium and folic acid supplement intended to help support the skeletal and cardiovascular systems in premenopausal, menopausal, and postmenopausal women. The new fast-dissolving CalciFol Chewable Wafers contain calcium carbonate, vitamin D3, magnesium, folic acid, vitamin B6, boron, and vitamin B12. One tablet in the morning is the recommended dosage.

NEW TREATMENT OPTION For Roche Pharmaceuticals, Nutley, N.J., (800) 526-6367, the FDA has approved Pegasys (peginterferon alfa-2a) and Copegus (ribavirin, USP) in combination for the treatment of patients co-infected with chronic hepatitis C and HIV. It is the first and only approved combination regimen for treating these coexisting conditions. Pegasys is dosed at 180 mcg as a once-weekly subcutaneous injection; Copegus is available as a 200-mg tablet and is administered orally two times a day as a split dose.

REINTRODUCTION TEVA Pharmaceuticals and Savient Pharmaceuticals, East Brunswick, N.J., have joined forces for the U.S. launch of TEV-TROPIN (somatropin [rDNA origin]) for injection. The growth hormone, a polypeptide of recombinant DNA origin, is indicated for the long-term treatment of children with short stature due to endogenous growth hormone deficiency. For further information, call TEVA at (215) 591-3030, or Savient at (732) 418-9300.

NEW GENERICS TEVA USA, North Wales, Pa., (888) TEVA USA, is introducing amoxicillin and clavulanate potassium chewable tablets USP. Available in 400 mg/57 mg strength in bottles of 20, the tablets are AB rated to GlaxoSmithKline's Augmentin, indicated for the treatment of lower respiratory tract infections, otitis media, sinusitis, skin and skin structure infections, and urinary tract infections.

Tentative approval has been granted to Ranbaxy Pharmaceuticals, Princeton, N.J., (609) 720-9200, for donepezil hydrochloride tablets in strengths of 5 mg and 10 mg. Indicated for the treatment of mild to moderate dementia of the Alzheimer's type, it offers a generic alternative to Eisai's Aricept.

Two companies are introducing pilocarpine tablets in 5-mg strength. The product is a generic version of MGI Pharma's Salagen 5-mg tablets. The medication is indicated for the treatment of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck in patients with Sjögren's syndrome. Pilocarpine tablets are available from Alpharma Inc., Fort Lee, N.J., (201) 947-7774 and from Roxane Laboratories, Columbus, Ohio, (614) 272-4774.