BRISTOL, Tenn., May 12 /PRNewswire-FirstCall/ -- King Pharmaceuticals,
Inc. (NYSE: KG) reported the receipt by its Meridian Technologies subsidiary
of a letter from the U.S. Food and Drug Administration ("FDA") advising the
Company that its Abbreviated New Drug Application ("ANDA") regarding King's
diazepam-filled auto-injector therapy for the emergency treatment of status
epilepticus and severe recurrent convulsive seizures associated with epilepsy
is not approvable. The FDA raised concerns regarding whether the product, a
self-injectible therapy, is appropriate for self-diagnosis and use. King is
currently evaluating how best to satisfy the concerns raised by the FDA with
the intent of amending or resubmitting the application.
King, headquartered in Bristol, Tennessee, is a vertically integrated
branded pharmaceutical company. King, an S&P 500 Index company, seeks to
capitalize on opportunities in the pharmaceutical industry through the
development, including through in-licensing arrangements and acquisitions, of
novel branded prescription pharmaceutical products in attractive markets and
the strategic acquisition of branded products that can benefit from focused
promotion and marketing and product life-cycle management.
This release contains forward-looking statements, which reflect
management's current views of future events and operations, including, but not
limited to, statements pertaining to the Company's plans to address the
concerns raised by the FDA with respect to the Company's diazepam-filled auto-
injector. These forward-looking statements involve certain significant risks
and uncertainties, and actual results may differ materially from the forward-
looking statements. Some important factors which may cause results to differ
include: dependence on the extent of King's success in addressing the concerns
raised by the FDA with respect to the diazepam-filled auto-injector;
dependence on the unpredictability of the duration and results of the FDA
review of any ANDA relating to King's diazepam-filled auto-injector and
dependence on the Company's compliance with FDA and other government
regulations that relate to its business. Other important factors that may
cause actual results to differ materially from the forward-looking statements
are discussed in the "Risk Factors" section and other sections of King's Form
10-K for the year ended December 31, 2003 and Form 10-Q for the first quarter
ended March 31, 2004, which are on file with the U.S. Securities and Exchange
Commission. King does not undertake to publicly update or revise any of its
forward-looking statements even if experience or future changes show that the
indicated results or events will not be realized.
SOURCE King Pharmaceuticals, Inc.
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Related links:
http://www.kingpharm.com
Company News On-Call:
http://www.prnewswire.com/comp/120319.html
CONTACT:
James E. Green, Executive Vice President,
Corporate Affairs, +1-423-989-8125, or Patrick J. O'Brien,
Director, Investor Relations, +1-423-989-7080, both of King
Pharmaceuticals, Inc.
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