Pill Identifier App

Makena

Treatment for Premature Labor

Update: Makena (hydroxyprogesterone caproate) Now FDA Approved - February 3, 2011

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)

Terms and conditions of use apply
Copyright © 2008 PR Newswire Association LLC. All rights reserved.
A United Business Media Company

Posted: October 2008

Related Articles

Makena (hydroxyprogesterone caproate) FDA Approval History

View comments

Hide
(web5)