New Product Newswire

RxNEW INDICATIONS There is good news for patients with non-Hodgkin's lymphoma. An expanded indication for Bexxar Therapeutic Regimen (tositumomab and Iodine I131 tositumomab), from GlaxoSmithKline, Philadelphia, (888) 825-5249, will allow patients to reap the potential benefits of the medication earlier in their course of treatment. Bexxar Therapeutic Regimen can now be used for the treatment of patients with CD 20 antigenexpressing relapsed or refractory low-grade, follicular, or transformed non-Hodgkin's lymphoma, whose disease has relapsed following chemotherapy. The original indication covered patients with disease that was refractory to rituximab and who had relapsed following chemotherapy. The regimen, intended as a single course of treatment, is not indicated for the initial treatment of patients with CD 20-positive non-Hodgkin's lymphoma.

NEW DOSAGE STRENGTHS Femhrt (norethindrone acetate/ethinyl estradiol), from Warner Chilcott Laboratories, Rockaway, N.J., (800) 521-8813, is now available in a new low-dose formulation. Femhrt 0.5 mg/2.5 mcg is indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause and for the prevention of postmenopausal osteoporosis. The new dosage strength is half that already available in femhrt 1 mg/5 mg.

NEW GENERICS Apotex Corp., Weston, Fla., (800) 706-5575, is shipping desmopressin acetate nasal spray, 0.01%, following final FDA approval of the product. Available as a nonrefrigerated formula, it is packaged in 5-mL bottles with a nasal pump dispenser. AB-rated to Sanofi-Aventis' DDAVP Nasal Spray, it is indicated for the management of primary nocturnal enuresis and as an antidiuretic replacement therapy in the management of central cranial diabetes insipidus.

Fougera, Melville, N.Y., (800) 645-9833, is introducing two new ophthalmic products to treat infections of the eye. Gentamycin sulfate ophthalmic ointment USP (Sterile) is available in 1/8-oz tubes, and gentamycin ophthalmic solution USP 0.3% (Sterile) comes in a 5-mL bottle. They provide generic versions of, respectively, Schering's Garamycin O.O. and Garamycin O.S.

Barr Laboratories, Woodcliff Lake, N.J., (201) 930-3300, has received tentative approval for two generic products. Mirtazapine orally disintegrating tablets, a version of Organon's Remeron Soltab Orally Disintegrating Tablets, 45 mg, are indicated for the treatment of depression. Final approval of the product in 15- and 30-mg strengths was granted earlier ... Estradiol and estradiol/norgestimate tablets, 1 mg and 1 mg/0.09 mg, are indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause, treatment of vulvar and vaginal atrophy, and prevention of osteoporosis. The tablets offer an alternative to Duramed Pharmaceuticals' Prefest Tablets in the same dosing strengths.

A tentative approval for finasteride tablets, 5 mg, has been granted to IVAX Pharmaceuticals, Miami, (305) 575-6000. Finasteride is a generic equivalent of Proscar, from Merck. The drug is used to treat benign prostatic hyperplasia.

NEW DEVICES Animas Corp., West Chester, Pa., (877) 937-7867, has FDA permission to market the IR 1250 Insulin Infusion Pump, the first such pump to store an extensive food database. Up to 500 items can be customized by the patient or selected from the CalorieKing 3,000 food-item database. Incorporation of such a database into the patient's regimen helps patients count their carbohydrates.

OTC Based near Boston, Tharos Laboratories, (888) TLI-LABS, is introducing Nytex, a blend of Procidin (a blueberry- and grape-derived antioxidant) and other ingredients that make up this sleep supplement. Nytex was formulated to promote and maintain normal sleep patterns, including relaxation, sleep initiation, sleep stability, and rejuvenation of the body. The ingredient Procidin contains proanythocyanidins, phytochemicals that are said to have immune-system, cardiovascular, urinary-tract, and neuroprotective properties.