Meda: Sublinox Registration Application Submitted to the FDA
Posted on: Thursday, 15 May 2008, 03:00 CDT
Regulatory News:
The registration application for Sublinox has been submitted to the US Food and Drug Administration (FDA). Sublinox (treatment of insomnia) contains zolpidem, a well-documented active substance, which is one of the world's most used substances for this disorder. Sublinox uses a unique, patented sublingual tablet formulation for fast, effective absorption. A recent phase III study confirmed that Sublinox gave faster onset of action than other zolpidem tablet formulations.
On 14 April, Meda (STO:MEDAA) acquired exclusive worldwide rights to Sublinox from Orexo, a Swedish pharma company. The greatest Sublinox sales potential is in the US, where Meda has its own marketing subsidiary, Meda Pharmaceuticals Inc. Market launch can be initiated after regulatory approval by the FDA. The submission to the FDA does not trigger a milestone payment to Orexo.
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.
This information was brought to you by Cision http://newsroom.cision.com
Source: Business Wire
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