Company Will Launch First Generic Adderall Product
POMONA, N.Y., Feb. 11 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc.
(NYSE: BRL) today announced that it has received approval from the U.S. Food &
Drug Administration for Dextroamphetamine Saccharate, Amphetamine Aspartate,
Dextroamphetimine Sulfate, Amphetamine Sulfate Tablets, 5 mg, 10 mg, 20 mg and
30 mg. This mixed salts of a single-entity amphetamine product is an AB rated
generic equivalent of Shire Richwood Inc.'s Adderall(R) tablets. The Company
expects to be the first to market generic Adderall and plans to launch the
product immediately.
"The approval of generic Adderall is among the Company's most significant
generic product launches and is a result of our ability to accelerate the
development of barrier-to-entry products to ensure that we reach the
marketplace before competitors," said Bruce L. Downey, Barr's Chairman and
CEO.
Adderall is indicated as an integral part of a total treatment program
which typically includes other remedial measures (psychological, educational,
social) for a stabilizing effect in children with behavioral syndrome
characterized by the following group of developmentally inappropriate
symptoms: moderate to severe distractibility, short attention span,
hyperactivity, emotional ability and impulsivity. Current annual sales are
approximately $345 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.
[EDITOR'S ADVISORY: Barr Laboratories, Inc. news releases are available
free of charge through PR Newswire's News On-Call fax service. For a menu of
Barr's previous releases, or to receive a specific release via fax call:
800-758-5804 -- ext. 089750. 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.]
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
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