K-V Pharmaceutical Announces Resubmission to New Drug Application for Gestivaâ„¢
ST. LOUIS, July 13 /PRNewswire-FirstCall/ -- K-V Pharmaceutical Company (NYSE: KVa/KVb) (the "Company"), a specialty pharmaceutical company, announced today that it has been informed by Hologic, Inc. (Nasdaq: HOLX ) that a resubmission to the FDA's Complete Response action letter received in January 2009 has been submitted for Gestiva™ (hydroxyprogesterone caproate injection), 250 mg/mL. If approved, Gestiva, commonly referred to as "17P," would be the first and only FDA-approved drug for the prevention of preterm birth in women who are pregnant with a single baby and have spontaneously delivered a single baby preterm in the past.
Greg Divis, President of Ther-Rx Corporation, the Company's branded subsidiary and Interim President and Chief Executive Officer of the Company, stated, "We believe this latest submission meets all the outstanding FDA requirements and marks an important milestone in the progression toward the potential approval and marketing of this product."
As previously announced, K-V has an agreement with Hologic, Inc. to secure the rights of Gestiva™ upon FDA approval.
About Preterm Birth
According to the March of Dimes, preterm birth, or the birth of a baby prior to 37 completed weeks of pregnancy, affects one in eight babies born in the United States(1). Additionally, the rate of preterm birth has increased more than 35 percent in the last 25 years(2), and is the leading cause for infant mortality and morbidity. Preterm birth is currently the number one cause of neonatal mortality, and babies b