6 July 2009
Synthon receives final approval for Bicalutamide 50mg
Synthon Pharmaceuticals, Inc. has received Final US FDA Approval on its ANDA for Bicalutamide 50mg tablets and the company is ready to ship its product.

This approval follows a series of European approvals that Synthon has been receiving for its bicalutamide product over the past two years, followed by launches in nearly all European countries.
Bicalutamide is the generic name for CASODEX® by AstraZeneca. The product is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate. The US market for the 50mg tablet, which is the currently approved dose of Bicalutamide, is around US$ 340 million.

Synthon’s Bicalutamide 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 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.

Casodex® is a trademark of AstraZeneca
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