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# FDA Denies Ipsen Somatuline Depot Petition
- URL: https://www.fdaweb.com/fda-denies-ipsen-somatuline-depot-petition/
- Published: 2024-05-23T12:00:00.000Z
- Updated: 2026-09-14T14:31:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157048

FDA has denied an Ipsen Pharmaceuticals 10/15/2019 petition asking that the agency take specific actions on any ANDA that references Ipsen’s Somatuline Depot (lanreotide acetate) subcutaneous solution. The FDA 5/21 [response](https://downloads.regulations.gov/FDA-2019-P-4830-0016/attachment%5F1.pdf?ref=fdaweb.com) says Ipsen asked that FDA require:

- ANDA applicants referencing Somatuline Depot to demonstrate bioequivalence through an *in vivo* study capable of demonstrating that a proposed generic product causes lanreotide acetate to release into systemic circulation at the same rate and to the same extent as the reference-listed drug (RLD) for the dosing interval;
- ANDAs to include comparable impurity analysis on samples of finished drug products and control for peptide-related impurities to the same extent and same level as the RLD;
- ANDAs to include comparative performance testing of the delivery device to ensure it is equivalently functional and useable;
- ANDA sponsors to conduct a partial Area Under the Curve analysis as part of the *in vivo* bioequivalence study to ensure the generic is bioequivalent to the RLD over the required dosing interval; and
- FDA to reissue its 7/2014 product-specific draft guidance based on its action on the petition.

The FDA petition denial made these points:

- the petition failed to show that *in vivo* bioequivalence evidence is required;
- FDA will assess a proposed generic drug’s impurity profile at the time of review and determine if it is acceptable;
- FDA does not agree that all ANDAs referencing Somatuline Depot should be required to include comparative use human factors data;
- for multiple reasons, FDA does not agree that ANDA applicants for generic Somatuline Depot should be required to perform a partial Area Under the Curve analysis; and
- since the petition action requests are denied, there is no need to reissue the product-specific guidance.