Watson's Generic Revatio® Receives FDA Approval
PARSIPPANY, N.J., Nov. 12, 2012
PARSIPPANY, N.J., Nov. 12, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc.
(NYSE: WPI) today announced that its subsidiary Watson Laboratories, Inc. has
received approval from the U.S. Food and Drug Administration (FDA) on its
Abbreviated New Drug Application (ANDA) for Sildenafil Tablets, 20 mg, the
generic equivalent to Pfizer's Revatio^®. Watson intends to begin shipping
the product in the near future. Revatio^® is indicated for the treatment of
pulmonary arterial hypertension in adults to improve exercise ability and
delay clinical worsening.
For the 12 months ending September 30, 2012, Revatio^® tablets had total U.S.
sales of approximately $339 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
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 iscommitted
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.
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 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.
Revatio^® is a registered trademark of Pfizer, Inc.
(Logo: http://photos.prnewswire.com/prnh/20100121/LA41294LOGO )
SOURCE Watson Pharmaceuticals, Inc.
Press spacebar to pause and continue. Press esc to stop.