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FDA approves Watson oral contraceptive

MORRISTOWN, N.J. — The Food and Drug Administration has approved the first and only low-dose oral contraceptive to combine 0.8-mg norethindrone and 0.025-mg ethinyl estradiol in a chewable form, with four 75-mg ferrous fumarate (iron) placebo tablets, Watson Pharmaceuticals has announced.

Watson's new oral contraceptive is positioned as a novel alternative to currently available birth control pills, and the dosing combination and 24-day active hormone regimen is intended to provide users with a low level of breakthrough bleeding and short, light, predictable periods.

"The approval of this oral contraceptive further strengthens Watson's robust and expanding branded Women's Health portfolio," stated Fred Wilkinson, EVP global brands. "We believe this product is an important addition to the oral contraceptive category, and that its characteristics will make it a desirable choice for women."

The contraceptive product, licensed from a subsidiary of Warner Chilcott, will actively be marketed to physicians by Watson's Global Brands division beginning in second quarter 2011.

The approval of the oral contraceptive is based on data from a 12-month, phase-3, multicenter, open-label study that evaluated the safety and efficacy of the product for pregnancy prevention. Among 1,251 women between the ages of 18 and 35 years who completed 12,297 treatment cycles, the pregnancy rate (Pearl Index) 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 weight gain (2.3%).

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