Coprexa 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 Status and FDA Approval Process for Coprexa
|Jan 29, 2008||Pipex Pharmaceuticals Provides Update on Coprexa (OralTetrathiomolybdate) New Drug Application|
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