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Watson Announces Novel Oral Contraceptive Approval
Date:12/22/2010

mong 1,251 women between the ages of 18 and 35 who completed 12,297 treatment cycles, the pregnancy rate (Pearl Index) in women was 2.01 pregnancies per 100 women-years of treatment.  In addition, women in the clinical trial reported short (mean duration of 3.7 days), predictable periods, with withdrawal bleeding beginning approximately on Day 27 or 28.

The most common adverse reactions (>/= 2%) reported while taking the oral contraceptive in a clinical trial included nausea/vomiting (8.8%), headaches/migraine (7.5%), depression/mood complaints (4.1%), dysmenorrhea (3.9%), acne (3.2%), anxiety symptoms (2.4%), breast pain/tenderness (2.4%), and increased weight (2.3%).

Nearly 11 million U.S. women use oral contraceptives to prevent pregnancy, and "the Pill" is the most common contraceptive method among women under 30 who practice contraception. The U.S. oral contraceptive market currently exceeds $4 billion annually and is dominated (86%) by combination (estrogen-progestin) pills.

Important Safety Information

Watson's new oral contraceptive is contraindicated in women with a high risk of arterial or venous thrombotic diseases, undiagnosed abnormal uterine bleeding, breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors or disease, and women who are pregnant.

The product does not protect against sexually transmitted infections (STI) or HIV.

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use.  Women who are over 35 years old who smoke should not use the product.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company. The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on urology and women's health. Watson has operations in many of the world's established and
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SOURCE Watson Pharmaceuticals
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