FDA rejects Pipex’s Coprexa new drug application

The FDA communicated a refusal to file, citing several issues including the adequacy of the analytical methodology to characterize the active pharmaceutical ingredient of Coprexa; a request to conduct an additional short term reproductive drug safety study in animals; four formatting and presentation items contained in the NDA; and two preliminary assessments concerning the adequacy of the clinical evidence of safety and efficacy of Coprexa.

Pipex said that it believes that the clinical and nonclinical deficiencies cited by the FDA were already agreed upon with the FDA during one of the two pre-NDA meetings held with a first review division of the FDA in August of last year. The Michigan-based pharmaceutical company said that the FDA’s subsequent transfer of review groups may have resulted in a loss of continuity of discussion, leading to the decision to refuse the application.

Pipex said that it plans to meet with the FDA to resolve the issue.