Company Launches Product Under Claravis(TM) Trademark
POMONA, N.Y., May 9 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc.
(NYSE: BRL) today announced that it has launched its AB-rated generic
equivalent version of Roche Pharmaceutical's Accutane(R) Capsules, 10 mg, 20
mg and 40 mg, under the trademark name Claravis(TM) (Isotretinoin Capsules,
USP). The U.S. Food & Drug Administration (FDA) approved the Company's
application to manufacture and market Claravis in April 2003.
The Company will promote Claravis to dermatologists using its sales force
that currently markets Trexall(TM) (Methotrexate Tablets, USP). Barr's
comprehensive education, risk assessment and management program for patients,
pharmacists and physicians includes, but is not limited to, a toll free
registration program for prescriber registration and education, a website for
healthcare professionals and patients, patient education materials designed to
inform patients about the risks associated with use of Claravis, and a
pregnancy prevention program. The risk management aspects of the program
include pregnancy testing and avoidance, patient awareness and consent to
avoid pregnancy, and awareness of psychiatric disorders prior to and during
therapy, because Claravis can cause birth defects.
Claravis is indicated for the treatment of severe recalcitrant nodular
acne. Because of significant adverse effects associated with its use,
Claravis should be reserved for patients with severe nodular acne who are
unresponsive to conventional therapy, including systemic antibiotics. In
addition, for female patients of childbearing potential, Claravis is indicated
only for those females who are not pregnant and will not become pregnant.
Claravis will compete in the Accutane marketplace that had total annual
sales of approximately $536 million for the most recent twelve months ended
March 2003.
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
report 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 difficulty in
predicting the timing and outcome of legal proceedings, including those
relating to patent challenge settlements and patent infringement cases; the
difficulty of predicting the timing of U.S. Food and Drug Administration, or
FDA, approvals; court and FDA decisions on exclusivity periods; the ability of
competitors to extend exclusivity periods past initial patent terms; market
and customer acceptance and demand for our pharmaceutical products;
reimbursement policies of third party payors; our ability to market our
proprietary products; the successful integration of acquired businesses and
products into our operations; the use of estimates in the preparation of our
financial statements; the impact of competitive products and pricing; the
ability to develop and launch new products on a timely basis; the availability
of raw materials; availability of any product we purchase and sell as a
distributor; the regulatory environment; fluctuations in operating results,
including spending for research and development, sales and marketing and
patent challenge activities; and, other risks detailed from time-to-time in
our filings with the Securities and Exchange Commission, or SEC. Forward-
looking statements can be identified by the use of words such as "expects,"
"plans," "will," "may," "anticipates," "believes," "should," "intends,"
"estimates," and other words of similar meaning. 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 statement. 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 or ccox@barrlabs.com
NOTE TO EDITORS: Barr news releases and corporate information are
also available on Barr's home page (www.barrlabs.com). For
complete indications, warnings and contraindications, contact
Barr Laboratories' Professional Services Department at 1-800-Barr
Lab. Claravis(TM) is a trademark of Barr Laboratories, Inc.
Accutane(R) is a registered trademark of Roche Pharmaceuticals.
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