Business · 28/10/2019Updated: 10/17/2026 · 1 min read

InvaGen Pharmaceuticals, Inc. Faces FDA Proposal to Withdraw Trandolapril Tablets Approval

Summary

The FDA is proposing to withdraw approval of an abbreviated new drug application for trandolapril tablets due to repeated failures in submitting required data to support bioequivalence, and is offering the ANDA holder the chance to request a hearing on the proposal.

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

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