FDA批准新的口服避孕药的组合产品

FDA Approves New Combination Product Oral Contraceptive
FDA批准新的口服避孕药的组合产品

The U.S. Food and Drug Administration today approved Natazia, a combination hormonal tablet for use as an oral contraceptive.
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' a* w' A) t- \4 s! Q( N7 }* JNatazia contains two female hormones, an estrogen (estradiol valerate) and a progestin (dienogest), and is the first four-phasic oral contraceptive marketed in the United States. Four-phasic refers to the doses of progestin and estrogen varying at four times throughout each 28-day treatment cycle.

“Nearly 12 million women in the United States and more than 100 million women worldwide currently use oral contraceptives,” said Scott Monroe, M.D., director of FDA’s Division of Reproductive and Urologic Products. “The approval of Natazia provides another option for women who choose to use an oral contraceptive as their method of contraception.”

The safety and efficacy of Natazia as an oral contraceptive was evaluated in two multicenter phase 3 clinical trials in North America and Europe. The trials involved 1,867 women and nearly 30,000 28-day treatment cycles. Natazia was found to be effective as a hormonal contraceptive in both studies.

' E! Z$ A1 ^: V6 d3 V9 JThe most common side effects observed with Natazia include irregular bleeding, breast tenderness, headaches, nausea and vomiting, increased weight, and acne. Women older than 35 who smoke should not use this product. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use.
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0 v4 f; x/ I' ONatazia is manufactured by Bayer HealthCare Pharmaceuticals of Wayne, N.J.

, k1 D* G' F% x6 Z( E4 @% T, |原文链接：http://www.fda.gov/NewsEvents/Ne ... ments/ucm211176.htm

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FDA Approves New Combination Product Oral Contraceptive
3 Y* g$ l3 p1 I1 ]3 M. i拜耳新复方口服避孕药获批在美上市
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( }. h: A" m7 L2010年5月6日，美国食品药品监督管理局（FDA）批准Natazia（一种激素类复方片剂）作为一种口服避孕药使用。

Natazia含两种女性激素：雌激素（戊酸雌二醇）和孕激素（地诺孕素），该药是首个在美国上市的四相（four-phasic）口服避孕药。四相是指在整个每28天治疗周期内的4次口服孕激素和雌激素的剂量各不相同。FDA生殖和泌尿学产品部门主任Scott Monroe博士表示，“有近1200万美国妇女和超过1亿的全球女性正在使用口服避孕药。Natazia的此次获批为使用口服避孕药作为其避孕方式的妇女提供了新的选择。”
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% c& T4 C3 d4 SNatazia作为一种口服避孕药，其安全性和有效性已在北美和欧洲进行的2项多中心3期临床试验中被评估。两项试验纳入了1867名妇女和近30000个28-天治疗周期，均已证实Natazia作为一种激素类避孕药是有效的。已观察到的Natazia的最常见副作用包括出血异常、乳房触痛、头痛、恶心和呕吐、体重增加和痤疮。35岁以上吸烟妇女不应使用本品。吸烟会增加因使用复方口服避孕药而引起的严重心血管事件的风险。Natazia由位于美国新泽西州Wayne市的拜耳医药健康保健公司（Bayer HealthCare Pharmaceuticals）生产。

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well，useful……