Perrigo and Synthon announce FDA final approval and launch of the generic version of Xyzal®

Synthon is announcing today that it has successfully concluded multiple registration procedures for Tamsulosin extended release tablets. Regulatory clearance has been obtained for Synthon's product in all relevant European countries.

Synthon's product is a fully generic version of Omnic Ocas® 0.4 mg extended release tablets and believes it is the first company worldwide to have secured approval for generic Tamsulosin tablets. The product contains the active ingredient Tamsulosin hydrochloride.

Omnic Ocas® is indicated for the treatment of benign prostatic hyperplasia. European sales of Tamsulosin tablets in 2009 were 181 million Euros based on IMS Midas data.

About Synthon
Synthon’s Tamsulosin tablets forms part of a rich pipeline of research projects and pending regulatory applications.

Synthon is a privately held specialty pharma company. With facilities in nine different countries, the company is dedicated to research, development, production, licensing and marketing of high quality alternatives to innovative medicines.

Omnic® and Ocas® are trademarks of Astellas Pharma Europe B.V.