CORONA, Calif., Dec. 29 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , 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 tablets, 0.15 mg / 0.02 mg and 0.01 mg and placebo tablets (28- day regimen). Desogestrel/ethinyl estradiol and ethinyl estradiol tablets, 0.15 mg / 0.02 mg and 0.01 mg and placebo tablets (28- day regimen) are the generic equivalent to Duramed Pharmaceuticals’ Mircette(R) low-dose monthly oral contraceptive product, which is indicated for prevention of pregnancy.” Rather than, "...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,” as originally issued inadvertently.
CORONA, Calif., Dec. 29 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , 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, 0.15 mg / 0.02 mg and 0.01 mg and placebo tablets (28- day regimen). Desogestrel/ethinyl estradiol and ethinyl estradiol tablets, 0.15 mg / 0.02 mg and 0.01 mg and placebo tablets (28- day regimen) are 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 January 2009 under the trade name Azurette(TM). For the 12-months ending September 2008, Mircette(R) had total U.S. sales of approximately $135 million, according to IMS Health data.
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 December 31, 2007.
Mircette(R) is a registered trademark of Duramed Pharmaceuticals, Inc.
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CONTACT: Patty Eisenhaur of Watson Pharmaceuticals, Inc., +1-951-493-5611
Web site: http://www.watsonpharm.com/
