POMONA, N.Y., Jan. 31 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc.
(NYSE: BRL) today announced that it has received approval from the U.S. Food &
Drug Administration for Fluoxetine Capsules, USP 10 mg, the generic equivalent
of Lilly's Prozac capsules. The Company expects to launch the product
immediately.
"With this approval, Barr now offers our customers both strengths of
generic Prozac capsule products," said Bruce L. Downey, Barr's Chairman and
CEO. "Since launch in August, our 20 mg capsule product has captured nearly
80% of the market. Approval to market this additional capsule strength gives
our customers an additional reason to maintain Barr as their generic Prozac
supplier of choice."
Fluoxetine Capsules, USP 10 mg is indicated for the treatment of
depression and for the treatment of obsessions and compulsions in patients
with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e.,
the obsessions or compulsions cause marked distress, are time-consuming, or
significantly interfere with social or occupational functioning. Current
annual sales for Prozac 10 mg capsules are $227.3 million.
Barr Laboratories, Inc. is a specialty pharmaceutical company engaged in
the development, manufacture and marketing of generic and proprietary
pharmaceuticals.
Safe Harbor Statement: To the extent that any statements made in this
release contain information that is not historical, these statements are
essentially forward-looking. These statements are subject to risks and
uncertainties that cannot be predicted or quantified and, consequently, actual
results may differ materially from those expressed or implied by such
forward-looking statements. Such risks and uncertainties include: the timing
and outcome of legal proceedings; the difficulty of predicting the timing of
U.S. Food and Drug Administration ("FDA") approvals; the court and FDA's
decisions on exclusivity periods; market and customer acceptance and demand
for new pharmaceutical products; ability to market proprietary products; the
impact of competitive products and pricing; timing and success of product
development and launch; availability of raw materials; the regulatory
environment; fluctuations in operating results; and, other risks detailed from
time-to-time in the Company's filings with the Securities and Exchange
Commission. Forward-looking statements can be identified by the use of words
such as "expects," "plans," "will," "believes," "estimates," "intends," "may"
and other words of similar meaning. Should known or unknown risks or
uncertainties materialize, or should our assumptions prove inaccurate, actual
results could vary materially from those anticipated. The Company undertakes
no obligation to publicly update any forward-looking statements.
SOURCE Barr Laboratories, Inc.
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Related links:
http://www.barrlabs.com
Company News On-Call:
http://www.prnewswire.com/comp/089750.html
CONTACT:
Carol A. Cox of Barr Laboratories, Inc.,
+1-845-348-6808, ccox@barrlabs.com
NOTE TO EDITORS: Barr Laboratories, Inc. news releases are
available free of charge through PR Newswire's News On-Call site
at http://www.prnewswire.com/corp/089750.html. Barr news
releases and corporate information are also available on Barr's
home page (http://www.barrlabs.com). For complete indications,
warnings and contraindications, contact Barr Laboratories'
Professional Services Department at 1-800-Barr Lab.
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