20 May 2009
Synthon first generic filer for Xyzal oral solution
Synthon Pharmaceuticals, Inc. (Synthon) believes that it is the ’Single First Filer’ of an ANDA with a Paragraph IV certification for the Xyzal® (levocetirizine) Oral Solution product.  As a result, Synthon expects to be eligible for 180 days of Hatch-Waxman exclusivity upon the first commercial marketing of their generic drug product. Synthon was also the single first filer of an ANDA for Xyzal tablets in December 2007.

Xyzal® is indicated for the relief of symptoms associated with allergic rhinitis (seasonal and perennial) and the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
The product contains the active ingredient levocetirizine, which is the enantiopure version of cetirizine, the active ingredient in UCB’s blockbuster product Zyrtec®.  In February 2008 UCB and Sanofi Aventis, who are co-marketing the product, announced the FDA approval of Xyzal® Oral Solution. The Oral Solution product offers an alternative for patients who have difficulty swallowing or who prefer liquid medication.

Synthon’s recent ANDA filing forms part of a rich pipeline of research projects and pending regulatory applications.  Synthon’s management is confident that the current PIV filing will bring considerable value to the company.
Synthon is a privately owned specialty pharma company. With facilities in seven different countries, the company is dedicated to research, development, production, licensing and marketing of high quality alternatives to innovative medicines.

For more information please contact PR@synthon.com, or call Synthon Pharmaceuticals, Inc.
at + 1 919 493 6006 .

For further information on Synthon Pharmaceuticals, Inc please see www.synthon-usa.com.
For further information on the Synthon group of companies, please see www.synthon.com.

Xyzal® is a trademark of UCB Pharma SA.
Zyrtec® is a trademark of UCB Pharma SA.
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