爱美津宣布美国FDA最终批准了仿制药版的Lysteda®

2016年8月2日

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美国新泽西州林德赫斯特, 2016年8月2日消息, 爱美津制药有限公司(爱美津)今天宣布,美国食品和药品管理局(FDA)最终批准了仿制药版的Lysteda®(氨甲环酸 650mg 即时释放药片)的简略新药申请(ANDA)。爱美津此前已经为该产品提交了ANDA,并做了第四类声明。

Ferring制药股份有限公司在美国销售Lysteda®以治疗周期性重度月经出血。 根据2015年与Ferring B.V.和Ferring International Center S.A达成的协议,爱美津可在将来生产其受许可的仿制药。

爱美津指出,这是其集产品开发和制造的苏州工厂的第四个获得暂定或最终FDA批准的简略新药申请。

Lyndhurst NJ, USA. August 2, 2016 – Amerigen Pharmaceuticals Limited (“Amerigen”) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company’s Abbreviated New Drug Application (ANDA) for a generic version of Lysteda® (Tranexamic Acid 650mg instant release tablets). Amerigen had previously filed an ANDA for the product and made a Paragraph IV certification.

Ferring Pharmaceuticals Inc. markets Lysteda® in the U.S. to treat cyclic heavy menstrual bleeding. Pursuant to a 2015 agreement with Ferring B.V. and Ferring International Center S.A., Amerigen may launch its generic product under license at an undisclosed future date.

Amerigen noted that this is the 4th ANDA receiving either tentative or final FDA approval from its product development and manufacturing facility located in Suzhou, China.


关于爱美津 About Amerigen

Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the US and China. The group is controlled by Amerigen Pharmaceuticals Limited. The US regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc., based in Lyndhurst, NJ, USA. The group's Chinese subsidiary, Suzhou Amerigen Pharmaceutical Company Limited, is located in Suzhou, Jiangsu Province. The group has products on the market currently in both the US and China plus an active portfolio of products under development, filed, or intended for filing, as ANDA's with the US FDA and the Chinese CFDA. Amerigen's focus is orally delivered products that are potential first generics, challenging to develop, require specialized technologies or high containment to manufacture, and present complex regulatory and intellectual property obstacles to bring to market. All Amerigen's products are developed and manufactured by the company or its partners around the world to meet the highest quality standards, including the US FDA.

爱美津制药致力于仿制药所涉及到的全部阶段的业务,是一家包括美国和中国多成员企业的集团公司。集团由爱美津制药控股。美国市场的注册和商业活动由位于新泽西州,林赫斯特的美国爱美津负责;集团的中国分公司,苏州爱美津制药有限公司,位于中国江苏省苏州市。爱美津制药集团目前在美国以及中国均有药品上市和销售,同时,我们拥有活跃的在研产品组,面向美国食品药品监督管理局(FDA)注册和已申报若干个仿制药品种(ANDA),并且计划开展向中国食品药品监督管理局(CFDA)注册和申报产品的工作。爱美津从事开发的口服制剂产品,是开发难度高,需要专门的技术,或生产要求高度严格管理控制,以及法规复杂,需要规避或挑战专利的仿制药。爱美津集团旗下公司或合作方开发和生产的所有产品,都满足高质量标准,包括美国FDA。