2019年5月8日
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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.”
美國新澤西州林德赫斯特2019年5月8日消息：愛美津制藥有限公司（愛美津）今天宣布，愛美津的青霉胺膠囊250mg的仿制藥申請已獲得美國食品和藥物管理局的最終批準。這是首個獲批的與Bausch Heath公司的Cuprimine®等效的仿制藥產品。該仿制藥產品在美國生產，并已由愛美津的子公司愛美津制藥股份有限公司于美國進行上市。
青霉胺膠囊可用于治療威爾遜氏病胱氨酸尿癥，以及對常規治療無效的嚴重活動性類風濕關節炎患者。
愛美津的總裁兼首席執行官John Lowry評論說：“我們很高興我們的青霉素胺膠囊的首仿產品上市。這是愛美津在美國上市的第九款產品，也是我們的第四款首仿產品，為美國醫療體系節省了大筆資金。”
關于愛美津 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.
愛美津制藥致力于仿制藥所涉及到的全部階段的業務，是一家包括美國和中國多成員企業的集團公司。集團由愛美津制藥控股。美國市場的注冊和商業活動由位于新澤西州，林赫斯特的美國愛美津負責；集團的中國分公司，蘇州愛美津制藥有限公司，位于中國江蘇省蘇州市。愛美津制藥集團目前在美國以及中國均有藥品上市和銷售，同時，我們擁有活躍的在研產品組，面向美國食品藥品監督管理局（FDA）注冊和已申報若干個仿制藥品種（ANDA），并且計劃開展向中國食品藥品監督管理局（CFDA）注冊和申報產品的工作。愛美津從事開發的口服制劑產品，是開發難度高，需要專門的技術，或生產要求高度嚴格管理控制，以及法規復雜，需要規避或挑戰專利的仿制藥。愛美津集團旗下公司或合作方開發和生產的所有產品，都滿足高質量標準，包括美國FDA。
