Columbia Laboratories, Inc. Comments On FDA Decision On Adeza Biomedical's Gestiva
Published: Oct 23, 2006
LIVINGSTON, N.J.--(BUSINESS WIRE)--The U.S. Food and Drug Administration (“FDA”) has issued an approvable letter to Adeza Biomedical for their synthetic progestogen, 17-alpha-hydroxyprogesterone caproate (trademarked “Gestiva”), Adeza’s candidate for prevention of recurrent preterm birth. Final FDA action is subject to the completion of an additional animal study and certain other conditions.