Le Lézard
Classified in: Health
Subject: FDA

Amerigen Announces U.S. FDA Approval For Generic Penicillamine 250 mg Capsules


LYNDHURST, N.J., May 8, 2019 /PRNewswire/ -- 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."

About Amerigen

Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the U.S. and China. The group is controlled by Amerigen Pharmaceuticals Limited. The U.S. regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc., based in Lyndhurst, NJ. 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 U.S. and China plus an active portfolio of products under development, filed, or intended for filing, as ANDA's with the U.S. FDA and the Chinese NMPA. Amerigen's focus is orally delivered products that are 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 U.S. FDA.

SOURCE Amerigen Pharmaceuticals


These press releases may also interest you

at 15:00
Immunostics Inc. (Boditech USA) and Dr. Scott Benson, an associate professor at the University of Utah Medical School, announce a COVID-19 testing solution and protocol for universities and colleges. With nearly all universities and colleges...

at 15:00
The "Technology Landscape, Trends and Opportunities in the Global 3D Printing Medical Device Market" report has been added to ResearchAndMarkets.com's offering. This report analyzes technology maturity, degree of disruption, competitive intensity,...

at 15:00
ADCO Hearing Products is manufacturing and selling face masks that address the issues that those who are hard of hearing experience wearing common masks, such as being unable to read lips and facial expressions, as well as uncomfortable ear straps....

at 15:00
Chief Executive Officer of MassageLuXe, a fast-growing luxury spa franchise, Mark Otter, recently was published by the Forbes Business Council. This is his first article to be featured by Forbes. The article, How Your Personal Services Business Can...

at 14:59
The Medical Board of California's decision to allow Dr. Arthur Park to continue practicing, despite a 20-year track record of negligence causing catastrophic injuries and death in the Bakersfield community, will unconscionably place even more...

at 14:50
The alprazolam market is poised to grow by USD 90.33 million during 2020-2024, progressing at a CAGR of over 4% during the forecast period. Request free sample pages Read the 159-page report with TOC on "Alprazolam Market Analysis Report by Type...



News published on 8 may 2019 at 15:34 and distributed by: