New product newswire: May 8, 2006

May 8, 2006

The FDA has approved OsmoPrep Tablets (sodium phosphate monobasicmonohydrate/sodium phosphate dibasic anhydrous) from SalixPharmaceuticals, Raleigh, N.C., (919) 862-1000. The product isindicated for bowel preparation for colonoscopy in adults age 18and older.

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NEW DRUGS

The FDA has approved OsmoPrep Tablets (sodium phosphate monobasic monohydrate/sodium phosphate dibasic anhydrous) from Salix Pharmaceuticals, Raleigh, N.C., (919) 862-1000. The product is indicated for bowel preparation for colonoscopy in adults age 18 and older.

NEW INDICATIONS

Remodulin (treprostinil sodium) Injection, from United Therapeutics, Silver Spring, Md., (301) 608-9292, has an expanded indication: to diminish the rate of clinical deterioration in patients with pulmonary arterial hypertension who require transition from Flolan. The approval covers both the subcutaneous and intravenous dosage forms.

Prograf (tacrolimus), from Astellas Pharma, Deerfield, Ill., (800) 888-7704, has received FDA approval for the prevention of graft rejection in heart transplant recipients. Prograf, in capsule and injection forms, were approved previously for the prevention of graft rejection in liver and kidney transplant patients.

GlaxoSmithKline's Relenza (zanamivir for inhalation), already approved for treating existing cases of flu, is now indicated for prevention of influenza A and B infections as well. According to the FDA, however, the drug is not to be used as a substitute for the flu vaccine. In clinical trials, the drug reduced the spread of flu in households where members were age five or older. GSK, Research Triangle Park, N.C., can be reached at (919) 483-2100.

Taxotere (docetaxel), used in combination with cisplatin and 5-fluorouracil, has been approved for the treatment of advanced stomach cancer, including cancer of the gastroesophageal junction, in patients with no prior chemotherapy for advanced disease. Taxotere, a product of the Sanofi-Aventis Group, Bridgewater, N.J., (908) 243-6000, was approved previously for treatment of breast cancer, nonsmall cell lung cancer, and prostate cancer.

NEW FORMULATIONS

A reformulated combination product from Accentia Biopharmaceuticals, Tampa, Fla., (813) 864-2554, offers a new strength in its narcotic constituent. Xodol (5 mg hydrocodone bitartrate and 300 mg acetaminophen tablets) allows physicians flexibility in the dose of hydrocodone without exceeding the maximum acetaminophen dose for the treatment of pain.