K-V Pharmaceutical Company Updates Status of New Drug Application for Gestivaâ„¢
ST. LOUIS, Jan. 12, 2011 /PRNewswire/ -- K-V Pharmaceutical Company (NYSE: KVa/KVb) today issued an update on the status of the U.S. Food and Drug Administration's review of Hologic, Inc.'s (Hologic) New Drug Application (NDA) for Gestiva™ (hydroxyprogesterone caproate injection) as a treatment for the prevention of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
Following the July 2010 resubmission of the NDA by Hologic, the FDA assigned a Prescription Drug User Fee Act ("PDUFA") action date of January 13, 2011. Hologic advised the Company that the FDA had recently requested additional information with respect to the Gestiva™ application. The requested information was provided to the FDA on January 10, 2011.
In order to provide for additional time to review the information that was solicited by the FDA and provided by Hologic, the FDA has extended the PDUFA date to April 13, 2011. Based on the information provided, the Company remains confident in the approval of Gestiva™ and believes a positive action by the FDA is likely on or before the new PDUFA date.
In light of this new information, the Company further stated that it is evaluating its liquidity outlook. When the Company completes its evaluation, it intends to furnish an update as appropriate.
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. Preterm birth is the leading cause for infant mortality and morbidity. Babies born preterm tend to grow more slowly, have more problems with their eyes, ears, breathing and nervous system, and experience more learning and behavioral problems. Preterm birth has been estimated to cost the United States more than $26 billion a year.
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