FDA Approves Astepro - Nasal Antihistamine In The Treatment Of Rhinitis

Main Category: Allergy
Also Included In: Ear, Nose and Throat;  Regulatory Affairs / Drug Approvals
Article Date: 17 Oct 2008 - 6:00 PDT

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The U.S. Food and Drug Administration (FDA) has approved Astepro - the new formulation of Astelin. Astepro Nasal Spray is an improvement over the marketed Astelin Nasal Spray and is better tolerated by patients using the new spray. The active substance in these products is azelastine - the leading nasal antihistamine in the treatment of rhinitis in the U.S.

Astepro is now approved for treatment of seasonal allergic rhinitis. Fewer reports of bitter taste and nasal discomfort were recorded by Astepro users and it was in general better tolerated than Astelin. Symptom relief, as recorded by patients, was also better. In total, about 1,400 patients were involved in Meda's phase III studies.

"Our development team has done an excellent work answering the questions from FDA and reaching approval in such a short time. This is an important milestone for Meda", said Anders Lönner, CEO Meda.

Full launch of Astepro in the U.S. will take place well before the next allergic rhinitis season.

MEDA AB (publ) is a leading international specialty pharma company. The company specialises in marketing and pharmaceutical development in late clinical stage. Acquisitions and long-term partnerships are fundamental factors that drive the company's strategy. Meda is represented by its own organisations in about 40 countries. Meda's products are sold in 120 countries worldwide. The Meda share is listed under Large Cap on the OMX Nordic Stock Exchange. Find out more, visit http://www.meda.se.