20. October 2009 00:38
Winston Laboratories, Inc. (“Winston Labs”), a wholly-owned subsidiary of Winston Pharmaceuticals, Inc. (OTC BB: WPHM) today announced that it has received a Notice of Non-compliance (“NON”) from the Therapeutics Drug Directorate, Health Canada (the “Directorate”) for its New Drug Submission (NDS) for CIVANEX (zucapsaicin cream 0.075%) for the treatment of the signs and symptoms of osteoarthritis. The Directorate remarked that the analysis of the pivotal trial did not support the requested indication. Winston Labs has a period of ninety days to submit a response to the Directorate's NON, which it intends to do.
"Winston Labs intends to fully address the comments in the NON, and believes that the clearly favorable risk-benefit profile of CIVANEX should lead to approval in Canada,” stated Joel E. Bernstein, MD, President and Chief Executive Officer of Winston Pharmaceuticals, Inc. "We believe CIVANEX represents an advance over current topical therapies for osteoarthritis as it is not absorbed, and thus has minimal risk for systemic side effects or interactions with other medications a patient might be using.”
Source Winston Pharmaceuticals
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