Business · 03/03/2021Updated: 10/17/2026 · 1 min read

PolyMedica Industries Inc., et al. Seek FDA Hearing on Withdrawal of New Drug Approvals

Summary

The FDA is proposing to withdraw approval of three new drug applications submitted by PolyMedica Industries Inc., et al., following repeated failure to submit required annual reports, and is offering NDA holders the opportunity to request a hearing on this proposal.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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