If Gestiva is approved, orphan drug designation provides the opportunity for seven years of US market exclusivity.
A new drug application for Gestiva, a long-acting injectable form of naturally occurring progesterone, was filed in the second quarter of 2006. In October 2006, Adeza announced receipt of an approvable letter for Gestiva from the FDA, subject to the completion of an additional rodent study and certain other conditions.
“Gestiva has the potential to significantly reduce preterm birth, improve neonatal outcomes and reduce associated health care costs in women with a history of preterm delivery,” said Emory Anderson, president and CEO.