紧急避孕药Plan B One-Step非处方适用年龄扩大至≥15岁

圣路易斯(MD Consult)——2013年4月30日，梯瓦制药宣布，美国食品药品管理局(FDA)已批准扩大紧急避孕药Plan B One-Step(左炔诺孕酮，1.5 mg)作为非处方药(OTC)的适用人群范围。从今以后，年龄≥15岁的消费者不必持处方即可购买该产品。此前的批准令规定该产品作为非处方药仅可销售给年龄≥17岁的消费者。

此外，从现在起消费者可从零售店购买该产品，而不再只能从药店购买。

该产品的标签已改为“不可卖予年龄小于15岁者或不能证实年龄者”。此外，该产品的外包装箱也将印有一个安全标志，并且采用硬塑料制作，以更有效地降低产品被偷取的风险。

据梯瓦制药介绍，在避孕失败或无保护性行为之后72 h内服用Plan B One-Step均可降低妊娠几率。然而，越早服用则效果越佳。Plan B One-Step并不是堕胎药，对已经发生的妊娠不会产生危害。

梯瓦制药提交的Plan B One-Step申请获得批准，并不会影响美国市场上其他已获准紧急避孕药的处方药状态。

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ST LOUIS (MD Consult) - On April 30, 2013, Teva announced that the US Food and Drug Administration (FDA) has expanded the age range to which the emergency contraceptive Plan B One-Step (levonorgestrel, 1.5 mg) may be sold over-the-counter (OTC). The product will now be available without a prescription to consumers aged 15 years and older. Previous approval restricted OTC sales to consumers aged 17 years and older.

In addition, the product will now be made available in store aisles, instead of behind pharmacy counters. The product will be available for sale during the retailer's normal operating hours, whether or not the pharmacy is open.

The product will now be labeled "not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified". If age-verification cannot be performed, or if the intended customer does not meet the age requirement, the sale cannot proceed. In addition to these measures at the point-of-sale, all product cartons will include a security tag as well as a hard plastic shell design for added security to reduce the possibility of theft.

According to Teva, Plan B One-Step can be taken up to 72 hours after birth control failure or unprotected sex to help decrease the chance of becoming pregnant; however, the sooner it is taken, the better it works. Plan B One-Step is not an abortifacient and will not harm an existing pregnancy.

The approval of Teva's application for Plan B One-Step does not affect the prescription status of the other approved emergency contraceptives in the US market.

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