Debiopharm Group (Debiopharm), a global biopharmaceutical development specialist that focuses on serious medical conditions and particularly oncology, announced today that Debiovision Inc., its Canadian affiliate, filed its Complete Response to the approvable letter received from the United States (U.S.) Food and Drug Administration (FDA) for Sanvar(R), or Debio 8609 (vapreotide acetate). The immediate release formulation of Sanvar(R), a somatostatin analogue, is used in the treatment of acute esophageal variceal bleeding (EVB).
The details can be read here.
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