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# Iroko Wants Apotex ANDA for Zorvolex Rejected
- URL: https://www.fdaweb.com/iroko-wants-apotex-anda-for-zorvolex-rejected/
- Published: 2018-01-24T12:00:00.000Z
- Updated: 2026-09-14T23:16:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140591

Iroko Pharmaceuticals is [asking](https://www.regulations.gov/contentStreamer?documentId=FDA-2018-P-0343-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) FDA not to approve an Apotex ANDA for a generic form of Zorvolex (diclofenac free acid) because the active ingredient in the proposed generic is not the same as that of Zorvolex, the reference-listed drug. Iroko also says that the ANDA should be rejected because the labeling for the proposed drug product cannot be the “same” as that approved for the RLD as required by FDA regulations.

“In addition to the active ingredient labeling differences,” the Iroko petition says, “the Zorvolex label contains a Warning that diclofenac free acid is not interchangeable with diclofenac salt formulations, including diclofenac sodium. This Warning cannot logically appear on the Apotex ANDA product label without causing confusion among prescribers and raising patient safety concerns. For both of these reasons, the Apotex ANDA cannot be approved as submitted and must be dismissed as required by FDA rules.”

According to the petition, although diclofenac free acid and diclofenac sodium have the same active moiety, they have different chemical structures, making them different active ingredients and not pharmaceutical equivalents. It notes that the *Orange Book* says that drug products are considered pharmaceutical alternatives if they contain the same therapeutic moiety but are different salts.