2019年5月8日
及時(shí)發(fā)布，請(qǐng)聯(lián)系：
美國(guó): (732) 993-9821
中國(guó): +86-512-6745-1085 分機(jī) 101
[email protected]
Lyndhurst NJ, USA, May 8, 2019 — Amerigen Pharmaceuticals Limited (“Amerigen”) today announced that Amerigen’s Abbreviated New Drug Application (“ANDA”) for Penicillamine Capsules USP 250 mg has received final approval from the U.S. Food and Drug Administration. This is the first such ANDA to be approved as a generic equivalent to Bausch Heath’s Cuprimine®. The finished product is manufactured for Amerigen in the U.S. where it has already been launched by Amerigen’s affiliate, Amerigen Pharmaceuticals, Inc.
Penicillamine Capsules USP are indicated in the treatment of Wilson’s disease, cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy.
John Lowry, Amerigen’s President and CEO, commented, “We are delighted to launch this first generic of Penicillamine Capsules. This is Amerigen’s ninth U.S. product launch and the fourth time we have brought a first generic to market, with important savings for the American healthcare system.”
美國(guó)新澤西州林德赫斯特2019年5月8日消息：愛(ài)美津制藥有限公司（愛(ài)美津）今天宣布，愛(ài)美津的青霉胺膠囊250mg的仿制藥申請(qǐng)已獲得美國(guó)食品和藥物管理局的最終批準(zhǔn)。這是首個(gè)獲批的與Bausch Heath公司的Cuprimine®等效的仿制藥產(chǎn)品。該仿制藥產(chǎn)品在美國(guó)生產(chǎn)，并已由愛(ài)美津的子公司愛(ài)美津制藥股份有限公司于美國(guó)進(jìn)行上市。
青霉胺膠囊可用于治療威爾遜氏病胱氨酸尿癥，以及對(duì)常規(guī)治療無(wú)效的嚴(yán)重活動(dòng)性類風(fēng)濕關(guān)節(jié)炎患者。
愛(ài)美津的總裁兼首席執(zhí)行官John Lowry評(píng)論說(shuō)：“我們很高興我們的青霉素胺膠囊的首仿產(chǎn)品上市。這是愛(ài)美津在美國(guó)上市的第九款產(chǎn)品，也是我們的第四款首仿產(chǎn)品，為美國(guó)醫(yī)療體系節(jié)省了大筆資金。”
關(guān)于愛(ài)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.
愛(ài)美津制藥致力于仿制藥所涉及到的全部階段的業(yè)務(wù)，是一家包括美國(guó)和中國(guó)多成員企業(yè)的集團(tuán)公司。集團(tuán)由愛(ài)美津制藥控股。美國(guó)市場(chǎng)的注冊(cè)和商業(yè)活動(dòng)由位于新澤西州，林赫斯特的美國(guó)愛(ài)美津負(fù)責(zé)；集團(tuán)的中國(guó)分公司，蘇州愛(ài)美津制藥有限公司，位于中國(guó)江蘇省蘇州市。愛(ài)美津制藥集團(tuán)目前在美國(guó)以及中國(guó)均有藥品上市和銷售，同時(shí)，我們擁有活躍的在研產(chǎn)品組，面向美國(guó)食品藥品監(jiān)督管理局（FDA）注冊(cè)和已申報(bào)若干個(gè)仿制藥品種（ANDA），并且計(jì)劃開(kāi)展向中國(guó)食品藥品監(jiān)督管理局（CFDA）注冊(cè)和申報(bào)產(chǎn)品的工作。愛(ài)美津從事開(kāi)發(fā)的口服制劑產(chǎn)品，是開(kāi)發(fā)難度高，需要專門(mén)的技術(shù)，或生產(chǎn)要求高度嚴(yán)格管理控制，以及法規(guī)復(fù)雜，需要規(guī)避或挑戰(zhàn)專利的仿制藥。愛(ài)美津集團(tuán)旗下公司或合作方開(kāi)發(fā)和生產(chǎn)的所有產(chǎn)品，都滿足高質(zhì)量標(biāo)準(zhǔn)，包括美國(guó)FDA。
