New product newswire

RX

NEW DRUGS

Taro Pharmaceuticals, Hawthorne, N.Y., (800) 544-1449, is introducing Lustra-Ultra (hydroquinone USP 4%), a third product in its Lustra line. Lustra-Ultra, with sunscreen, retinol, antioxidants, and moisturizers added to its formulation, is indicated for the gradual treatment of ultraviolet-induced dyschromia and the discoloration resulting from oral contraceptive use, pregnancy, hormone replacement therapy, or skin trauma.

Now available in the United States is Bioniche Life Sciences' treatment for small, uncomplicated varicose veins of the lower extremities. Sotradecol Injection (sodium tetradecyl sulfate injection) is packaged in 2-ml vials in strengths of 1% or 3%. Bioniche is headquartered in Belleville, Ontario, Canada, at (416) 815-0700.

NEW INDICATIONS

Adderall XR (CII) (mixed salts of a single-entity amphetamine product) has been granted an expanded indication. The drug, from Shire Pharmaceuticals Group, Wayne, Pa., (484) 595-8800, is now approved for treating attention deficit/hyperactivity disorder in adolescents aged 13 to 17. It was approved earlier for ADHD treatment in children aged six to 12 years and in adults 18 years of age and older.

NEW FORMULATIONS

An extended-release formulation of Allegra D is available from the Sanofi-Aventis Group, Bridgewater, N.J., (908) 243-6000. Allegra D 24 Hour (fexofenadine HCl 180 mg/pseudoephedrine HCl 240 mg) Extended Release Tablets combine once-daily Allegra (for seasonal allergies) with round-the-clock relief from nasal congestion. The drug is suitable for adults and children 12 years of age and older.

NEW GENERICS

West-Ward Pharmaceutical Corp., Eatontown, N.J., (732) 542-1191, has several new entries to its product line. Cefuroxime injection, providing a generic alternative to GlaxoSmithKline's Zinacef, is available in 750-mg, 1.5-gm, and 7.5-gm strengths and is indicated for treating lower respiratory tract infections, urinary tract infections, skin and skin-structure infections, septicemia, meningitis, uncomplicated and disseminated gonococcal infections, and bone and joint infections ... Isosorbide mononitrate extended-release, 60 mg, an alternative to AstraZeneca's Imdur, is indicated for the prevention of angina pectoris due to coronary artery disease ... Ergotamine tartrate and caffeine 1 mg/100 mg, bioequivalent to Novartis' Cafergot, is used as therapy to abort or prevent vascular headache ... Epinephrine injection, 1 mg/ mL, is indicated for the relief of respira-tory distress due to bronchospasm, relief of hypersensitivity reactions to drugs and other allergens, and to prolong the action of infiltration anesthetics.

Fexofenadine hydrochloride capsules, 60 mg, have been FDA-approved for Barr Laboratories, Woodcliff Lake, N.J., (800) 222-0190. A generic alternative to Aventis' Allegra, in the same strength, the newly approved capsules are used to relieve symptoms associated with seasonal rhinitis and to treat uncomplicated skin manifestations of chronic idiopathic urticaria in adults and in children six years of age and older.

The Perrigo Co., Allegan, Mich., (260) 673-9451, has FDA approval to manufacture and market prescription 400-, 600-, and 800-mg ibuprofen tablets, a generic alternative to McNeil Consumer's Motrin tablets in the same strength. The tablets are indicated for the relief of the symptoms of arthritis and relief of mild to moderate pain.