Debiopharm files complete response to FDA for Sanvar
Swiss drugmaker Debiopharm says that its Canadian affiliate has filed a complete response to the "approvable letter" received from the US Food and Drug Administration for Sanvar (vapreotide acetate), a somatostatin analog for the treatment of acute esophageal variceal bleeding.
Last summer, the firm completed a confirmatory Phase III EVB study in the USA that took place in over 20 centers and enrolled 103 patients including 70 that qualified for the intention-to-treat analysis. The results formed a large component of the complete response that was submitted to the FDA on September 30.
Debiopharm has already signed license agreements for the sales and marketing of Sanvar with several commercial partners that include Salix Pharmaceuticals in the USA, Ranbaxy Laboratories in India, EMS Sigma Farma in Brazil, LG Life Sciences in Korea, Tzamal Bio-Pharma in Israel and Medical Futures in Canada.
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