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# Exela Wants Nicardipine PDUFA Fee Refund
- URL: https://www.fdaweb.com/exela-wants-nicardipine-pdufa-fee-refund/
- Published: 2021-03-24T12:00:00.000Z
- Updated: 2026-09-14T16:52:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148947

Exela Pharma Sciences is asking FDA to refund FY 2021 PDUFA user fees assessed against the company’s nicardipine HCl injection and stop assessing user fees in the future. A 3/18 [citizen petition](https://downloads.regulations.gov/FDA-2021-P-0308-0001/attachment%5F1.pdf?ref=fdaweb.com) says that to help facilitate the prompt refund of the user fees that were “improperly assessed,” Exela asks that FDA assign a therapeutic equivalence (TE) code to its product.

The petition says the agency originally approved the Exela nicardipine NDA in 2008 based in part on a finding that the reference-listed drug, Cardene, was safe and effective. The agency assigned an AP TE code at the time, Exela says.

By 2/2018, both Cardene and an ANDA generic version had been discontinued and FDA removed them from the Active section of the *Orange Book*, leaving the Exela product as a single-source drug. FDA then removed its TE code and began assessing annual PDUFA fees for the Exela nicardipine NDA.

In 5/2020, the petition says, American Regent reintroduced the previously approved generic nicardipine product and FDA restored it to the Active section of the *Orange Book*. “As a result of that development,” the petition says, “Exela’s nicardipine NDA product no longer is a single-source product and its AP rating promptly should be restored because Exela’s nicardipine NDA product and American Regent’s nicardipine ANDA product are inherently bioequivalent parenteral products. At the very least, Exela’s nicardipine NDA product is entitled to a BX rating.”

The company says that regardless of which TE rating its product receives, there is no longer any basis for assessing PDUFA user fees against it under the law’s Same Product Exemption.