- PROVIGIL Label Revised; Now in Line with NUVIGIL Label Approved Last June
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FRAZER, Pa., Sept. 17 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq:
CEPH) today announced that it has finalized and shared with healthcare
professionals revisions to the label for PROVIGIL(R) (modafinil) Tablets
[C-IV], its wake-promoting agent. As announced by the company in both March
and June of this year, these changes were necessary to make the PROVIGIL
label consistent with the NUVIGIL(TM) (armodafinil) Tablets [C-IV] label
approved and made available by the U.S. Food and Drug Administration (FDA)
in June 2007. NUVIGIL is the single isomer formulation of modafinil, the
active ingredient contained in PROVIGIL. The labels for PROVIGIL and
NUVIGIL can be found on http://www.cephalon.com.
PROVIGIL and NUVIGIL each are indicated to improve wakefulness in
adults with excessive sleepiness associated with obstructive sleep
apnea/hypopnea syndrome (OSAHS), shift work sleep disorder and narcolepsy.
In OSAHS, PROVIGIL and NUVIGIL are indicated as adjuncts to standard
treatment(s) for the underlying obstruction. PROVIGIL and NUVIGIL are not
approved for use in pediatric patients for any indication.
Cephalon's ongoing development program is evaluating the use of NUVIGIL
as a treatment for serious psychiatric and neurological medical conditions.
The company currently plans a commercial launch of NUVIGIL once additional
clinical data has been amassed.
About Cephalon, Inc.
Cephalon, Inc. is an international biopharmaceutical company, recently
inducted in to the World Economic Forum Community of Global Growth
Companies. For 20 years, the company has been dedicated to the discovery,
development and commercialization of innovative products in four core
therapeutic areas: central nervous system, pain, oncology and addiction.
Cephalon has delivered a seven-year compound annual growth rate (CAGR)
through 2006 greater than 75% and 2006 revenue of $1.760 billion. A member
of the Fortune 1000, Cephalon currently employs approximately 3,000 people
in the United States and Europe. U.S. sites include the company's
headquarters in Frazer, Pennsylvania, and offices, laboratories or
manufacturing facilities in West Chester, Pennsylvania, Salt Lake City,
Utah, and suburban Minneapolis, Minnesota. Cephalon's European headquarters
are located in Maisons-Alfort, France.
The company's proprietary products in the United States include:
PROVIGIL, FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX(R) (arsenic
trioxide) injection, AMRIX(TM) (cyclobenzaprine hydrochloride
extended-release capsules), VIVITROL(R) (naltrexone for extended-release
injectable suspension), GABITRIL(R) (tiagabine hydrochloride), NUVIGIL and
ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]. The company also
markets numerous products internationally. Full prescribing information on
its U.S. products is available at http://www.cephalon.com or by calling
1-800-896-5855.
In addition to historical facts or statements of current condition,
this press release may contain forward-looking statements. Forward-looking
statements provide Cephalon's current expectations or forecasts of future
events. These may include statements regarding anticipated scientific
progress on its research programs; development of potential pharmaceutical
products; interpretation of clinical results; manufacturing development and
capabilities; market prospects for its products; sales and earnings
guidance; and other statements regarding matters that are not historical
facts. You may identify some of these forward-looking statements by the use
of words in the statements such as "anticipate," "estimate," "expect,"
"project," "intend," "plan," "believe" or other words and terms of similar
meaning. Cephalon's performance and financial results could differ
materially from those reflected in these forward-looking statements due to
general financial, economic, regulatory and political conditions affecting
the biotechnology and pharmaceutical industries as well as more specific
risks and uncertainties facing Cephalon such as those set forth in its
reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and
Exchange Commission. Given these risks and uncertainties, any or all of
these forward-looking statements may prove to be incorrect. Therefore, you
should not rely on any such factors or forward- looking statements.
Furthermore, Cephalon does not intend to update publicly any
forward-looking statement, except as required by law. The Private
Securities Litigation Reform Act of 1995 permits this discussion.
SOURCE Cephalon, Inc.
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Related links:
http://www.cephalon.com
http://www.prnewswire.com/comp/134563.html/
CONTACT:
Media, Sheryl Williams, +1-610-738-6493,
swilliam@cephalon.com, Jenifer Antonacci, +1-610-738-6674,
jantonacci@cephalon.com, or Investors, Robert (Chip) Merritt,
+1-610-738-6376, cmerritt@cephalon.com, all of Cephalon, Inc.
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