FDA Requests More Information On Meda AB's New Azelastine Formulation

STOCKHOLM, Sweden--(BUSINESS WIRE)--Regulatory News: 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.

MEDA AB (publ) is an international specialty pharma company that concentrates on marketing and market-adapted product development. Acquisitions and long-term partnerships are fundamental factors that drive the company’s strategy. Meda is represented with own organisations in 26 countries and with more than 1 500 employees within marketing and sales. Meda’s products are sold in approximately 120 countries world-wide. The Meda share is listed under Large Cap on the OMX Nordic Stock Exchange. Find out more, visit www.meda.se.

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Contact: MEDA AB Investor Relations: Anders Larnholt, +46 8 630 19 62 / +46 709 458 878 anders.larnholt@meda.se

Source: Meda