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FDA Information

Mometasone was approved by the FDA back in 1987.

The branded version Nasonex® was approved by the U.S. Food and Drug Administration (FDA) in December 2004 for the treatment of nasal polyps in patients 18 years of age and older. Nasonex® has also received approval for the treatment of nasal polyps in 13 European countries via the European Union's Mutual Recognition Procedure. The countries involved in the Mutual Recognition Procedure were the United Kingdom, which acted as the Reference Member State, Austria, Belgium, Denmark, Finland, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal and Spain. 

In addition, Nasonex® received approval for nasal polyps in France (February 2005) and Sweden (May 2005). 

 

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