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# FDA Denies Ferring Reconsideration Petition
- URL: https://www.fdaweb.com/fda-denies-ferring-reconsideration-petition/
- Published: 2025-08-19T12:00:00.000Z
- Updated: 2026-09-14T15:19:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159714

FDA has denied a 12/4/2022 petition submitted by Ferring Pharmaceuticals asking the agency to reconsider its denial of a 2/10/2022 petition asking that FDA require ANDA sponsors citing Ferring’s Firmagon (degarelix) as the reference-listed drug to conduct *in vivo* bioequivalence studies and update the agency’s draft product-specific guidance for degarelix acetate with that requirement. The denial of the petition for reconsideration says Ferring asserted that the agency failed to adequately consider several critical issues, “unnecessarily exposing patients to serious risk.”

FDA says its review indicated that the relevant information and views in the administrative record were adequately considered when it denied the initial petition. It makes these points:

- FDA adequately considered the statistical analysis presented in the initial petition;
- FDA adequately considered the Patil *et. al.* study in the initial petition;
- FDA adequately considered the risk of treatment failure for patients with advanced prostate cancer;
- FDA’s bioequivalence recommendations for degarelix acetate align with agency regulations and policies;
- the agency adequately considered the relevant information and views in the administrative record; and
- the public interest and the interest of justice do not support reconsideration of the decision.

“You have not demonstrated that relevant information or views in the administrative record were not previously or adequately considered when we denied the initial petition…,” FDA concludes. “Additionally, we do not find that granting the reconsideration petition would be in the public interest or the interest of justice. The reconsideration petition thus fails to meet the standards for granting a petition for reconsideration … \[and\] therefore your reconsideration petition is denied.”