Watson Pharmaceuticals Receives FDA Final Approval for Generic Mircette(R)
Inc. (NYSE: WPI), a leader in generic and specialty branded pharmaceuticals,
today announced that its subsidiary, Watson Laboratories, Inc., has received
final approval from the United States Food and Drug Administration on its
Abbreviated New Drug Application (ANDA) for desogestrel/ethinyl estradiol and
ethinyl estradiol tablets USP, 0.15 mg / 0.02 mg. Desogestrel/ethinyl
estradiol and ethinyl estradiol tablets, USP, is the generic equivalent to
Duramed Pharmaceuticals’ Mircette(R) low-dose monthly oral contraceptive
product, which is indicated for prevention of pregnancy.
Watson intends to launch the product in early
name Azurette(TM). For the 12-months ending
total U.S. sales of approximately
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading specialty pharmaceutical company
that develops, manufactures, markets, sells and distributes generic and
specialty brand pharmaceutical products. Watson pursues a growth strategy
combining internal product development, strategic alliances and collaborations
and synergistic acquisitions of products and businesses. For press releases
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; patents and other
intellectual property rights held by third parties; 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 Annual Report
on Form 10-K for the year ended
Mircette(R) is a registered trademark of Duramed Pharmaceuticals, Inc.
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SOURCE Watson Pharmaceuticals, Inc.