Stellar Pharmaceuticals Inc. Announces Watson Pharma, Inc. Has Received A Conditional IDE Approval For Stellar's Uracyst(R) From The FDA

Main Category: Urology / Nephrology
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 11 Jun 2009 - 0:00 PDT

email to a friend   printer friendly   opinions  

Stellar Pharmaceuticals Inc. ("Stellar" or the "Company") (OTCBB:SLXCF) is pleased to announce that its United States licensee, Watson Pharma, Inc. ("Watson") (NYSE:WPI), has received a conditional approval of their Investigational Device Exemption (IDE) to conduct clinical work with Uracyst® from The Food and Drug Administration (FDA) in the United States of America ("USA"). This will allow Watson to continue to move their Uracyst® development program forward towards the eventual approval for the sale of Uracyst® in USA. The conditional approval allows Watson to begin a blinded, placebo-controlled, pilot clinical trial in 100 subjects at 20 clinical study centers in the USA.

Peter Riehl, Stellar's President and CEO stated, "We are very pleased to see another important milestone completed by Watson as they continue to make progress towards the sale of Uracyst® in the largest pharmaceutical market in the world. Stellar is fortunate to have a partner as experienced as Watson is in the field of urology to develop the clinical program for the Uracyst marketing approval in the USA."

Source
Stellar

• Additional
• References
• Citations