Makena
Generic name: hydroxyprogesterone caproate
Treatment for: Premature Labor
Update on Gestiva PDUFA Date
KV Provides Update on Gestiva PDUFA Date
ST. LOUIS, October 20, 2008 /PRNewswire-FirstCall/ -- KV Pharmaceutical Company announced today that it was advised by Hologic, Inc., the holder of the New Drug Application (NDA) for Gestiva, that the U.S. Food and Drug Administration (FDA) has extended the PDUFA date on Gestiva for ninety days from October 24, 2008 to January 25, 2009. The ninety-day extension is in line with the FDA's standard operating procedure when it receives updated data from the applicant seeking the NDA.
Under the terms of the previously announced agreement, KV will acquire ownership of the Gestiva NDA from Hologic upon payment of KV's final milestone payment of $72.5 million that will become due upon FDA marketing approval for the product and KV's receipt of adequate commercial launch quantities.
KV reiterates that the revised PDUFA date is not expected to impact KV's plans regarding the timing of the launch of Gestiva during the second half of fiscal 2009.
KV Pharmaceutical Company is a fully integrated specialty pharmaceutical company that develops, manufactures, markets, and acquires technology-distinguished branded and generic/non-branded prescription pharmaceutical products. The company markets its technology distinguished products through ETHEX Corporation, a national leader in pharmaceuticals that compete with branded products, and Ther-Rx Corporation, its branded drug subsidiary.
For further information about KV Pharmaceutical Company, please visit the company's corporate website at .
CONTACT: Catherine M. Biffignani, Vice President, Investor Relations, KVPharmaceutical Company, +1-314-645-6600
Web site: http://www.kvpharmaceutical.com/
Ticker Symbol: (:KVA KVB)
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Posted: October 2008
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Makena (hydroxyprogesterone caproate) FDA Approval History
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