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# FDA Denies Metacel Ozobax Petition
- URL: https://www.fdaweb.com/fda-denies-metacel-ozobax-petition/
- Published: 2024-12-10T12:00:00.000Z
- Updated: 2026-09-14T14:49:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158337

FDA has denied a Metacel Pharmaceuticals 8/18/2023 petition asking that the agency require ANDA sponsors relying on Ozobax (baclofen) oral solution as the reference-listed drug to conduct testing and provide data to address the safety of any flavoring ingredient and to reject any requests from generic drug sponsors to waive the tests. The denial [letter](https://downloads.regulations.gov/FDA-2023-P-3574-0003/attachment%5F1.pdf?ref=fdaweb.com) first corrects the company’s statement in the petition that it had been required to conduct additional studies to support the safety of the proposed cherry flavor.

FDA says that while a drug master file deficiency letter said there was no nonclinical information to support the safe use of the flavor, that did not mean the company was required to conduct nonclinical studies. It cites a variety of ways in which nonclinical information could be provided.

“Applicants for proposed generic baclofen oral solution products containing flavors must provide information demonstrating that such flavors do not affect the safety or efficacy of the proposed drug product,” the letter says. “Because Ozobax is indicated for chronic use, such information must support the safety of the flavor in the proposed drug product for chronic use…. \[S\]afety determinations regarding flavors in ANDAs are dependent upon the specific facts of each application and different types of evidence can be provided to support the safety of a proposed flavor.”