FDA requests more information on new azelastine formulation

The U.S. Food and Drug Administration (FDA) has requested more information on Meda’s new drug application concerning azelastine hydrochloride nasal spray in a new formulation. Meda will initiate a discussion with the FDA to understand and clarify the needs of FDA and what steps need to be taken before the application may be approved. This process is anticipated to take several months before conclusion.

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