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FDA approves Apotex azelastine nasal spray

The FDA has approved a generic equivalent to Meda’s Astepro, an azelastine nasal spray, 0.1876MG, manufactured by Apotex. Meda filed a patent infringement suit in January 2012 after Apotex submitted its ANDA. The two companies settled after a similar suit regarding Apotex’s generic version of Astelin in 2008.

View the FDA approval history.

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published on September 5, 2012

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