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

Thursday, May 9, 2019 General News
Email Print This Page Comment bookmark
Font : A-A+

The first generic version of Penicillamine Capsules USP is now approved in the U.S.

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.

Cision View original content:http://www.prnewswire.com/news-releases/amerigen-announces-us-fda-approval-for-generic-penicillamine-250-mg-capsules-300846665.html

SOURCE Amerigen Pharmaceuticals



Post your Comments

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
* Your comment can be maximum of 2500 characters
I agree to the terms and conditions

News A - Z

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

News Search

Medindia Newsletters

Subscribe to our Free Newsletters!

Terms & Conditions and Privacy Policy.

Press Release Category

Press Release Archive

Stay Connected

  • Available on the Android Market
  • Available on the App Store