News : dymista

Dymista has received medical approval in Europe via the decentralized registration procedure. Dymista is approved for the treatment of seasonal and perennial allergic rhinitis. National registration processes, including negotiations regarding pricing and reimbursement, will now follow in each country prior to launch. Launches are anticipated in 2013 in several countries.

"Patients in Europe that suffer from...

The U.S. Food and Drug Administration (FDA) has approved Dymista, a new patented product for treatment of seasonal allergic rhinitis (SAR). In several clinical studies, Dymista has consistently showed a rapid and more complete symptom relief than standard treatment.

"Allergic rhinitis is an increasing problem. Many patients have severe symptoms that cause inability to work and live a normal life. Dymista can offer...

Meda announced today positive results of three studies of MP29-02 (tentatively called Dymista), a novel intranasal formulation of azelastine hydrochloride and fluticasone propionate. The first study demonstrated that continuous treatment with MP29-02 for 1 year was well tolerated in patients with chronic allergic or non-allergic rhinitis, only 2.7% of patients treated with MP29-02 and 2.9% of patients treated with...

FDA, the U.S. Food and Drug Administration, has informed Meda that the PDUFA (Prescription Drug User Fee Act) date for Dymista will be early May 2012. FDA needs an additional three months to review earlier submitted data, related to CMC (Chemistry, Manufacturing and Controls). The extension of the timeline is in line with FDA’s standard review regulations.

The marketing authorization application for Dymista (a novel formulation of azelastine hydrochloride and fluticasone propionate) has been filed in Europe. The application uses a decentralized procedure and the reference member state is Germany.

Dymista is a nasal spray formulation for patients with symptomatic treatment of moderate to severe allergic rhinitis and rhinoconjuctivitis. The efficacy and safety of...