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鲁宾复方口服避孕药左炔诺孕酮炔雌醇片获FDA批准

来源:生物谷 2013-01-23 17:12

2013年1月23日讯 /生物谷BIOON/ --鲁宾(Lupin)宣布,复方口服避孕药左炔诺孕酮炔雌醇片(0.1mg/0.02mg)上市许可申请获得了FDA的批准。该药为华生(Waston)Lutera 28片的等价仿制药。(生物谷bioon.com)

英文原文:FDA clears Lupin combined oral contraceptive medication
PBR Staff Writer
Published 23 January 2013
The US FDA has issued marketing approval for Lupin Pharmaceuticals' Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.1mg / 0.02mg, the combined oral contraceptive.

Levonorgestrel and Ethinyl Estradiol Tablets are the generic equivalent to Watson Laboratories' Lutera 28 tablets indicated to prevent pregnancy in women.

Lupin is expected to begin the product marketing soon.

The safety and efficacy of levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets were established in a multicenter open-label trial conducted for 12 months.

Around 2,185 women between 18 to 41 years of age participated in the study, completing the equivalent of 20,937 28-day cycles of exposure.

Combination of oral contraceptives works by inhibiting ovulation while other probable mechanisms include cervical mucus changes and endometrial changes, which inhibit sperm penetration and reduce the chance of implantation respectively.

 

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