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# Ferring Wants Restrictions on Firmagon Generics
- URL: https://www.fdaweb.com/ferring-wants-restrictions-on-firmagon-generics/
- Published: 2022-02-22T12:00:00.000Z
- Updated: 2026-09-14T17:33:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151212

Ferring Pharmaceuticals is asking FDA to put restrictions on any section 505(j) ANDA and 505(b)(2) NDA citing the company’s Firmagon (degarelix acetate) for subcutaneous injection to treat patients with advanced prostate cancer. In a 2/9 [petition](https://www.regulations.gov/document/FDA-2022-P-0160-0001?ref=fdaweb.com), Ferring asks for a determination that any generic ANDA or follow-on NDA relying on a showing of bioequivalence or comparative bioavailability to Firmagon must be tested in human subjects.

“Based on Ferring’s many years of experience with Firmagon and our understanding of the variables that may influence the degarelix depot formed by the product, patient safety and patient benefit cannot be assured if generic and follow-on versions of degarelix are not subject to testing in human subjects,” the petition says. “Ferring is not aware of any scientific evidence showing that *in vitro* testing and *in vitro* parameters correlate with *in vivo* drug release from a degarelix drug depot. Therefore, absent an adequate *in vivo* study, it would be a matter of speculation and assumption that a proposed generic or follow-on product would exhibit systemic drug release equivalent to Firmagon.”

Specifically, FDA asks that FDA: 

- require ANDAs that reference Firmagon and 505(b)(2) applications that rely on bioequivalence data or comparative bioavailability data to conduct an appropriate *in vivo* study capable of demonstrating that a proposed drug product causes degarelix acetate to release into systemic circulation at the same rate and to the same extent as the reference-listed drug over the course of the dosing interval;
- require ANDA and 505(b)(2) sponsors to conduct partial area under the curve analysis as part of the *in vivo* bioequivalence study to ensure the generic is bioequivalent to the reference-listed drug over the required dosing interval; and
- reissue a draft guidance based on the actions taken in response to the petition.