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Coprexa FDA Approval Status

FDA Approved: No
Brand name: Coprexa
Generic name: tetrathiomolybdate
Company: Pipex Pharmaceuticals, Inc.
Treatment for: Wilson's Disease

Coprexa (tetrathiomolybdate) is an oral, small-molecule, anti-copper agent intended for the treatment of initially presenting neurologic Wilson’s disease.

In January 2008, Pipex Pharmaceuticals, Inc. announced the receipt of a Refusal to File Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for Coprexa (oral tetrathiomolybdate) had not been accepted by the FDA for further review as submitted.

Development timeline for Coprexa

DateArticle
Jan 29, 2008Pipex Pharmaceuticals Provides Update on Coprexa (OralTetrathiomolybdate) New Drug Application

Further information

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