The US Food and Drug Administration (FDA) has approved the first low-dose oral contraceptive regimen to combine 0.8 mg norethindrone and 0.025 mg ethinyl estradiol in chewable form, with four 75-mg ferrous fumarate placebo tablets.
The 24/4 regimen, marketed by Watson Pharmaceuticals, Inc, a subsidiary of Global Brands under license from Warner Chilcott plc, is intended to decrease breakthrough bleeding and provide short, light, predictable periods.
"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," said Fred Wilkinson, executive vice president of Global Brands, in a company news release.
FDA approval was based on data from a 1-year, phase 3, multicenter, open-label study of 1251 women aged 18 to 35 years (12,297 treatment cycles). Results showed a pregnancy rate of 2.01 per 100 women-years of treatment. Mean period duration was short (3.7 days) and predictable, beginning on day 27 or 28.
Adverse events associated with use of the iron-boosted regimen 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%).
As with other combination oral contraceptive regimens, the safety labeling for the 24/4 norethindrone 0.8 mg/ethinyl estradiol 0.025 mg regimen includes a boxed warning advising against its use in women smokers older than 35 years, citing an increased risk for serious cardiovascular events.
Marketing will begin in the second quarter of 2011.
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