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迈兰推出口服避孕药Nordette28仿制药

来源:生物谷 2012-12-30 15:14

2012年12月29日讯 /生物谷BIOON/ --迈兰(Mylan)宣布,乙炔诺孕酮炔雌醇片(Levonorgestrel and Ethinyl Estradiol Tablets)简化新药申请(ANDA)获得了FDA的批准,该药为梯瓦(Teva)Nordette 28的仿制药。迈兰已即刻启动了药物的装运。
Nordette 28是一种口服左炔诺孕酮和炔雌醇避孕药,每片含有0.15mg的左诀诺孕酮和0.03克的炔雌醇。(生物谷bioon.com)

英文原文:

Mylan announced that it has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Levonorgestrel and Ethinyl Estradiol Tablets, the generic version of Teva's Nordette 28. 

Nordette 28 is an oral progestin and estrogen combination tablet indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Levonorgestrel and Ethinyl Estradiol Tablets are available in a 0.15mg/0.03mg dosage strength and are being shipped immediately.

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