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# FDA Denies Fresenius Glycopyrrolate Petition
- URL: https://www.fdaweb.com/fda-denies-fresenius-glycopyrrolate-petition/
- Published: 2023-01-19T12:00:00.000Z
- Updated: 2026-09-14T18:12:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153575

FDA has denied a 7/22/22 Fresenius Kabi petition asking the agency to designate the company’s glycopyrrolate intramuscular, intravenous solution 0.6 mg/3 mL as therapeutically equivalent (TE) with an AP rating to Hikma Pharmaceutical’s Robinul (glycopyrrolate injection 0.2 mg/mL). The agency’s 1/18 [response](https://downloads.regulations.gov/FDA-2022-P-1656-0003/attachment%5F1.pdf?ref=fdaweb.com) says that Robinul is no longer available for sale and is on the Discontinued Drug Product List section of the *Orange Book*.

“A drug product that is on the Prescription Drug Product List (commonly referred to as the ‘Active Section’ of the *Orange Book* cannot have a TE code with respect to a drug product in the Discontinued Drug Product List,” the letter explains.