A product of Farmacon-IL LLC, Westport, Conn., (203) 222-8801,NeoProfen (ibuprofen lysine) Injection is indicated to close a"clinically significant" patent ductus arteriosus in prematureinfants weighing 500-1500 grams and who are no more than 32 weeksof gestational age, after fluid restriction, diuretics, andrespiratory support have proven ineffective.
A product of Farmacon-IL LLC, Westport, Conn., (203) 222-8801, NeoProfen (ibuprofen lysine) Injection is indicated to close a "clinically significant" patent ductus arteriosus in premature infants weighing 500-1500 grams and who are no more than 32 weeks of gestational age, after fluid restriction, diuretics, and respiratory support have proven ineffective.
Sicor Pharmaceuticals is introducing deferoxamine mesylate for injection, USP, a generic alternative to Novartis' Desferal. Available in 500 mg/vial and 2 gm/vial single-dose vials, it is indicated for the treatment of acute iron intoxication and of chronic iron overload due to transfusion-dependent anemias.
Zonisamide capsules, in 25-, 50-, and 100-mg strengths, from TEVA USA, North Wales, Pa., (888) TEVA USA, are bioequivalent to Dainippon Pharmaceutical's Zonegran. Zonisamide is used as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.
Mylan Pharmaceuticals, Pittsburgh, (724) 514-1800, has received tentative approval for two generic drugs. Fexofenadine hydrochloride tablets, offering an alternative to Aventis Pharmaceuticals' Allegra Tablets, are indicated for treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. They are available in 30-, 60-, and 180-mg strengths. Finasteride tablets USP, available in 5-mg strength, provide an alternative to Merck's Proscar Tablets in the same strength and are used to treat benign prostatic hyperplasia.
NEW DELIVERY SYSTEM
Nektar Therapeutics, San Carlos, Calif., (650) 631-3100, has developed the Advanced PEGylation delivery system that will be used with UCB Pharma's Cimzia, an injectable drug for treating Crohn's disease. Cimzia, upon FDA approval, will be the first antibody to utilize this delivery system, permitting Crohn's patients to be treated by subcutaneous injection instead of IV infusion.