Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


FDA refuses to file Pipex’s Coprexa

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pipex believes that FDA's transfer of the NDA for Coprexa (oral tetrathiomolybdate) from the initial review division that conducted pre-NDA meetings to a new review division is the reason that the agency refused to file the application for initially-presenting neurologic Wilson's disease. The NDA was transferred to the other division in late December because a medical group in that division had expertise in diseases resulting from inborn metabolic errors. "Pipex believes that the clinical and nonclinical deficiencies cited by the FDA were already discussed, resolved and agreed upon with FDA during … pre-NDA meetings," the firm said Jan. 29 (1Pharmaceutical Approvals Monthly October 2007, In Brief). Pipex maintains the citations are substantive review issues and should be considered during review of the NDA. Pipex and FDA are scheduled to meet by the end of February to discuss the RTF decision...

You may also be interested in...

Pipex expects November NDA filing for Coprexa

Ann Arbor-based Pipex Pharmaceuticals anticipates filing its lead compound, Coprexa (oral tetrathiomolybdate), in November for the treatment of initially-presenting neurologic Wilson's disease, the firm announces Sept. 21 after completing pre-NDA meetings with FDA. Pipex is also developing oral tetrathiomolybdate - an oral small-molecule, anti-copper agent - for fibrotic disorders...

Mylan Weighs In On Coronavirus Drug Shortage Concerns

Hours before the US FDA confirmed the first drug shortage due to active pharmaceutical ingredient constraints because of the coronavirus situation in China, generics industry leader Mylan came under pressure about the potential impact on its business. 


Eyes On Pricing As Zolgensma Moves Closer To Japan Market

Government advisory committee gives initial nod to what will become Japan’s most expensive single drug, but reimbursement pricing could come in for close scrutiny.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts