Adeza Biomedical has received an approvable letter for Gestiva, a long-acting form of a naturally occurring progesterone designed to prevent preterm birth. The FDA granted priority review for the drug, as it would be the first therapy to prevent preterm delivery. In August, an FDA expert advisory panel recommended approval of Adeza BioMedical's Gestiva but said that the agency should require a post-marketing study to monitor the safety of the drug. Now, the agency has informed Adeza that approval of the drug is subject to the completion of an additional animal study and certain other conditions. The drug developer said it would meet with the FDA to determine what steps need to be taken for approval.
- read this BusinessWeek report
Committee votes in favor of Adeza's Gestiva. Report
FDA to give Gestiva priority review. Report