PARSIPPANY, N.J., Jan. 3, 2013 /PRNewswire/ -- Watson
Pharmaceuticals, Inc. (NYSE: WPI) today announced that its
subsidiary Watson Laboratories, Inc. – Florida has received approval from the U.S.
Food and Drug Administration (FDA) on its Abbreviated New Drug
Application (ANDA) for tranexamic acid tablets, the generic
equivalent to Ferring Pharmaceuticals' Lysteda®.
Watson intends to begin shipping the product immediately.
Lysteda® is indicated for the treatment of cyclic heavy menstrual
bleeding. Ferring B.V. has filed lawsuits against Watson,
alleging that Watson's ANDA product infringes U.S. Patent Nos.
7,947,739, 8,022,106, and 8,273,795. The litigations remain
pending.
For the 12 months ending November 30,
2012, Lysteda® had total U.S. sales of approximately
$25 million according to IMS Health
data.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. (NYSE: WPI) is a global,
integrated specialty pharmaceutical company focused on developing,
manufacturing and distributing generic, brand and biosimilar
products. The Company has global and U.S. headquarters in
Parsippany, New Jersey, USA, and
international headquarters in Zug, Switzerland.
Watson is the world's third-largest generics prescription drug
manufacturer, with more than 750 products marketed globally through
operations in more than 60 countries. Watson's global branded
pharmaceutical business develops and markets products principally
in Urology and Women's Health, and is committed to developing
and marketing biosimilars products in Women's Health, Oncology and
other therapeutic categories. In addition, Watson is the
fourth-largest U.S. generic pharmaceutical product distributor
through its Anda, Inc. business, and also develops and out-licenses
generic pharmaceutical products outside of the U.S. through its
Medis third-party business. Watson has announced that it will
adopt a new global name – Actavis – effective in 2013.
For press release and other company information, visit Watson
Pharmaceuticals' Web site at http://www.watson.com.
Forward-Looking Statement
Statements contained in this press release that refer to
non-historical facts are forward-looking statements that reflect
Watson's current perspective of existing information as of the date
of this release. It is important to note that Watson's goals and
expectations are not predictions of actual performance. Actual
results may differ materially from Watson's current expectations
depending upon a number of factors, risks and uncertainties
affecting Watson's business. These factors include, among others,
the difficulty of predicting the timing and outcome of the pending
patent litigation and risks that an adverse outcome in such
litigation could render Watson liable for substantial damages; the
impact of competitive products and pricing; the timing and success
of product launches; difficulties or delays in manufacturing; the
availability and pricing of third party sourced products and
materials; successful compliance with FDA and other governmental
regulations applicable to Watson and its third party manufacturers'
facilities, products and/or businesses; changes in the laws and
regulations, including Medicare and Medicaid, affecting among other
things, pricing and reimbursement of pharmaceutical products; and
such other risks and uncertainties detailed in Watson's periodic
public filings with the Securities and Exchange Commission,
including but not limited to Watson's Quarterly Report on Form 10-Q
for the quarter ended September 30,
2012 and Watson's Annual Report on Form 10-K for the year
ended December 31, 2011. Except as
expressly required by law, Watson disclaims any intent or
obligation to update these forward-looking statements.
Lysteda® is a registered trademark of Ferring B.V.
CONTACTS:
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Investors:
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Lisa
DeFrancesco
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(862)
261-7152
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Media:
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Charlie
Mayr
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(862)
261-8030
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SOURCE Watson Pharmaceuticals, Inc.