Magazine article Drug Topics

New Products

Magazine article Drug Topics

New Products

Article excerpt



New Rx

FDA has approved naloxone hydrochloride injection {Evzio; Kaleo, Inc.), the first hand-held auto-injector to reverse opioid overdose that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. The product delivers a single dose of the drug naloxone by means of a device that can be carried in a pocket or stored in a medicine cabinet. The product is sold with a trainer device, enabling the family member or caregiver to practice administration in advance of need, (

Sunovion has announced that eslicarbazepine acetate (Aptiom) [1], an antiepileptic used as adjunctive treatment for partial-onset seizures, is now available in U.S. phannacies in 200-mg, 400-mg, 600-mg, and 800-mg dosages. It can be taken whole or crushed, with or without food, (

FDA has approved Biogen Idec's Coagulation Factor IX (Recombinant), Fc Fusion Protein, (Alprolix) [2], for treatment of adults and children with hemophilia B. The company says that the product is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding. (

Novo Nordisk has announced the U.S. availability of Coagulation Factor XIII A-Subunit [Recombinant] (Tretten), used for the routine prophylaxis of bleeding in people with congenital factor XIII (FXIII) A-subunit deficiency, which is a serious, rare bleeding disorder with limited treatment options. The company states that this product is the only recombinant treatment for this condition. (

FDA recently approved a product from Stallergenes S.A. (Oralair) that combines freeze-dried extracts from the pollens of five grasses, including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal, and Timothy, to treat allergic rhinitis (hay fever) with or without conjunctivitis (eye inflammation) induced by certain grass pollens in people ages 10 through 65 years. Oralair is tire first sublingual (under tire tongue) allergen extract approved in tire United States, After the first dose is administered by tire healthcare provider and tire patient observed for potential adverse reactions, subsequent doses can be taken at home. Because of tire potential for severe allergic reactions, tire prescribing infonnation includes a boxed warning and there is a Medication Guide for patients, (www. )

FDA has approved Merck, Sharp & Dohnre's Ragwitek, tire first allergen extract administered under tire tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflammation), in adults 18 years through 65 years of age. Treatment with the once-daily Ragwitek tablet begins 12 weeks before the start of ragweed pollen season and continues throughout the season. A healthcare provider administers the first dose and observes tire patient for 30 minutes. Subsequent doses may be taken by the patient at home. Because severe allergic reaction is possible, tire product has a boxed warning and a companion Medication Guide. (

FDA has also approved Merck's Timothy Grass pollen allergen extract tablet for sublingual use (Grastek) for tire treatment of Timothy Grass pollen-induced allergic rhinitis, with or without conjunctivitis, in individuals aged 5 to 65 years, with the understanding that autoinjected epinephrine will be available to patients at home. …

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