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# FDA Withdrawing InvaGen Trandolapril ANDA
- URL: https://www.fdaweb.com/fda-withdrawing-invagen-trandolapril-anda/
- Published: 2019-10-29T12:00:00.000Z
- Updated: 2026-09-15T01:59:31.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145360

Federal Register notice: FDA is proposing to withdraw approval of an InvaGen Pharmaceuticals ANDA for trandolapril tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this action. The basis for the proposal is that the company has repeatedly failed to submit required data to support a finding of bioequivalence for the ANDA. Previous bioanalytical studies to support the ANDA were conducted by Cetero Research, which was found to be engaged in improper conduct (document falsification and sample manipulation). After requesting new bioequivalence data, InvaGen notified the agency that the product is no longer marketed. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-10-28/pdf/2019-23461.pdf?ref=fdaweb.com).