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news.The US Food and Drug Administration (FDA) has approved Watson Pharmaceuticals' oral contraceptive product.
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Watson Pharma claims that its contraceptive product is the first and only low dose oral contraceptive to combine 0.8mg norethindrone and 0.025mg ethinyl estradiol in chewable form, with four 75mg ferrous fumarate (iron) placebo tablets.
Taken orally, once daily, the product is proven effective in lowering the risk of pregnancy, Watson said.
The pregnancy preventive pill is intended to provide users with a low level of breakthrough bleeding and short, light, predictable periods.
The approval is supported by a 12-month, Phase 3 trial’s data that investigated the safety and efficacy of the product for pregnancy prevention.
Watson Pharma Global Brands executive vice president Fred Wilkinson said the approval of this oral contraceptive further strengthens Watson’s branded Women’s Health portfolio.
"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," Wilkinson said.