Registration
Application For Azelastine Extra Strength Submitted To
The FDA
ADVERTISING
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The registration application for azelastine nasal spray
in the new formulation with Extra Strength has been submitted
to the US Food and Drug Administration (FDA), seeking approval
to treat symptoms of Seasonal Allergic Rhinitis and Perennial
Allergic Rhinitis.
The new formulation is patent pending. Six phase III studies
evaluating efficacy and safety and a long term safety have
been conducted involving about 1,600 patients treated with
azelastine Extra Strength. The higher strength has been
shown to offer additional symptom relief with maintained
safety profile.
In addition, the application seeks approval of a once
or twice daily treatment regimen.
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.
