Synthon Receives Final Approval for Tamsulosin, AB-rated to Flomax®

Research Triangle Park, North Carolina 27 April 2010 - Synthon Pharmaceuticals, Inc. has received final approval from the US Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for tamsulosin hydrochloride 0.4mg capsules. The company is ready to immediately ship its product.

Since its first generic tamsulosin launch in Europe six years ago, Synthon has been the largest producer of tamsulosin in Europe and is now ready to enter the US market.

Tamsulosin is an alpha1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia. Flomax® is marketed in the US by Boehringer Ingelheim and Astellas Pharma. The US market for the product was around $2.2 billion during 2009 according to WoltersKluwer Health.

About Synthon:
Synthon’s tamsulosin ANDA forms part of a rich pipeline of research projects and pending regulatory applications and is another example of its strategy to bring affordable quality alternatives to innovative products to market at the earliest possible date.

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.

Flomax® is a registered trademark of Astellas Pharma, Inc.

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For more information please contact PR@synthon.com.
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.