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# Court Remands Amgen Dispute to FDA for Further Consideration
- URL: https://www.fdaweb.com/court-remands-amgen-dispute-to-fda-for-further-consideration/
- Published: 2018-01-26T12:00:00.000Z
- Updated: 2026-09-14T23:17:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140611

The Washington DC District Court has remanded to FDA an Amgen lawsuit against the agency over its denial to grant pediatric exclusivity for the company’s Sensipar (cinacalcet hydrochloride). In its complaint, Amgen argued that FDA’s decision to grant an earlier pediatric exclusivity award to Johnson & Johnson’s Ortho Tri-Cyclen (ethinyl estradiol; norgestimate) was inconsistent with its denial for Sensipar. The court agreed and remanded the dispute to FDA for the “limited purpose of addressing whether the agency’s prior decision granting pediatric exclusivity for Ortho Tri-Cyclen is consistent with its decision denying pediatric exclusivity for Sensipar and, if not, whether there is a reasoned explanation for the disparate outcomes.”

In a 1/26 [court-issued opinion](https://ecf.dcd.uscourts.gov/cgi-bin/show%5Fpublic%5Fdoc?2017cv1006-76&ref=fdaweb.com), judge **Randolph Moss** said Amgen has a point that the Ortho Tri-Cyclen decision may be inconsistent. In an earlier reconsideration decision for Sensipar, FDA distinguished the agency’s grant of exclusivity for Ortho Tri-Cyclen on the ground that studies conducted by Ortho Tri-Cyclen’s sponsor, Johnson & Johnson (J&J), met all of the terms of the written request. “As Amgen argues, however, it is — at best — unclear from the administrative record whether that premise is correct,” the judge said while siding with Amgen’s contention that women enrolled in a related J&J study did not meet the study criteria.