Watson Pharmaceuticals Receives FDA Approval for Generic PLAN B(R) for Over-the-Counter Use
August 28 2009 - 4:01PM
PR Newswire (US)
MORRISTOWN, N.J., Aug. 28 /PRNewswire-FirstCall/ -- Watson
Pharmaceuticals, Inc. (NYSE:WPI), a leading specialty
pharmaceutical company, today announced that its subsidiary, Watson
Laboratories, Inc., has received approval today from the United
States Food and Drug Administration (FDA) on its Abbreviated New
Drug Application (ANDA) for Levonorgestrel Tablets, 0.75 mg for
over-the-counter use in women ages 17 and above, as well as for
prescription use in women under the age of 17. Levonorgestrel
Tablets, 0.75 mg is the generic equivalent to Duramed
Pharmaceuticals' PLAN B (Rx/OTC), which is indicated for the
prevention of pregnancy following unprotected intercourse or
contraceptive failure. For the 12-months ending June 30, 2009, PLAN
B had total U.S. sales of approximately $135 million. Watson will
market the product under the trade name Next Choice(TM) and plans
to launch the product shortly. On June 24, 2009, Watson received
FDA approval of Next Choice(TM) (levonorgestrel) Tablets, 0.75 mg
for prescription use. Following today's approval, Next Choice(TM)
is now labeled for both prescription and over-the-counter use.
About Watson Pharmaceuticals, Inc. Watson Pharmaceuticals, Inc. is
a global leader in the development and distribution of
pharmaceuticals with a broad portfolio of generic products and a
specialized portfolio of brand pharmaceuticals focused on Urology,
Women's Health and Nephrology/Medical. For press release and other
company information, visit Watson Pharmaceuticals' Web site at
http://www.watson.com/. Forward-Looking Statement Any statements
contained in this press release that refer to future events or
other non-historical facts are forward-looking statements that
reflect Watson's current perspective of existing trends and
information as of the date of this release. Except as expressly
required by law, Watson disclaims any intent or obligation to
update these forward-looking statements. Actual results may differ
materially from Watson's current expectations depending upon a
number of factors affecting Watson's business. These factors
include, among others, the impact of competitive products and
pricing; market acceptance of and continued demand for Watson's
products; difficulties or delays in manufacturing; the difficulty
of predicting the timing or outcome of FDA or other regulatory
agency approvals or actions, if any; and 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 period ended June
30, 2009. PLAN B is a registered trademark of Women's Capital
Corporation, a subsidiary of Duramed Pharmaceuticals, Inc. (Logo:
http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO)
http://www.newscom.com/cgi-bin/prnh/20020214/WATSONLOGO
http://photoarchive.ap.org/ DATASOURCE: Watson Pharmaceuticals,
Inc. CONTACT: Patty Eisenhaur of Watson Pharmaceuticals, Inc.,
+1-973-355-8141 Web Site: http://www.watson.com/
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