FDA Defers Final Action on milnacipran New Drug Application
October 20 2008 - 8:00AM
PR Newswire (US)
NEW YORK and SAN DIEGO, Oct. 20 /PRNewswire-FirstCall/ -- Forest
Laboratories, Inc. (NYSE:FRX) and Cypress Bioscience, Inc.
(NASDAQ:CYPB) (the "Companies") today announced that the U.S. Food
and Drug Administration (FDA) has advised the Companies that it was
not able to take final action by the scheduled Prescription Drug
User Fee Act action date of October 18, 2008, on their New Drug
Application for milnacipran, a selective serotonin and
norepinephrine reuptake inhibitor for the management of
fibromyalgia. The FDA has not requested any additional information
from the Companies but did indicate that a clinical data question
related to the NDA submission required confirmation. The FDA
indicated that their assessment could be completed in a matter of
weeks, but could not confirm specific timing. The FDA could not
provide further information as to the reason for the delay. The
Companies continue to plan for a first quarter 2009 product launch
meeting. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) About
Forest Laboratories Forest Laboratories (NYSE:FRX) is a U.S.-based
pharmaceutical company with a long track record of building
partnerships and developing and marketing products that make a
positive difference in people's lives. In addition to its
well-established franchises in therapeutic areas of the central
nervous and cardiovascular systems, Forest's current pipeline
includes product candidates in all stages of development and across
a wide range of therapeutic areas. The company is headquartered in
New York, NY. To learn more about Forest Laboratories, visit
http://www.frx.com/. Except for the historical information
contained herein, this release contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995. These statements involve a number of risks and
uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical
products, the impact of competitive products and pricing, the
timely development and launch of new products, and the risk factors
listed from time to time in Forest Laboratories' Annual Report on
Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent SEC
filings. About Cypress Bioscience Cypress Bioscience, Inc. is
developing therapeutics and personalized medicine services, to
facilitate improved and individualized patient care. Cypress' goal
is to address the evolving needs of specialist physicians and their
patients by identifying unmet medical needs in the areas of pain,
rheumatology, and physical medicine and rehabilitation, including
challenging disorders such as fibromyalgia and rheumatoid
arthritis. We intend to use this approach to improve patient care
and create a unique partnership with physicians. For more
information about Cypress, please visit the Company's website at
http://www.cypressbio.com/. This press release, as well as Cypress'
SEC filings and website at http://www.cypressbio.com/, contain
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 including statements about
the potential of milnacipran to treat fibromyalgia syndrome, that
the FDA review may be completed in a matter of weeks and that
Cypress continues to plan for a first quarter 2009 product launch
meeting for milnacipran. Actual results could vary materially from
those described as a result of a number of factors, including those
set forth in Cypress' Annual Report on Form 10-K, the most recent
Quarterly Report on Form 10-Q and any subsequent SEC filings and
including, but not limited to, milnacipran may not ever receive
marketing approval from the FDA and even if it does, that the FDA
review may take longer than weeks to complete, that the FDA may
request additional information from Cypress and that the
milnacipran launch may be delayed such that it may not occur in the
first quarter of 2009.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGODATASOURCE:
Forest Laboratories, Inc.; Cypress Bioscience, Inc. CONTACT: Forest
Laboratories, Inc., Frank Murdolo, Vice President - Investor
Relations, +1-212-224-6714, ; or Cypress Bioscience, Inc., Michael
Hufford, Ph.D., Vice President - Corporate Development or Mary
Gieson, Investor Relations, +1-858-452-2323, Web Site:
http://www.cypressbio.com/ http://www.frx.com/ Company News
On-Call: http://www.prnewswire.com/comp/329163.html
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