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# FDA Denies Insys’ Syndros Petition
- URL: https://www.fdaweb.com/fda-denies-insys-syndros-petition/
- Published: 2018-04-10T12:00:00.000Z
- Updated: 2026-09-14T23:58:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141184

FDA has denied a 11/8/17 Insys Therapeutics petition asking that it decline to approve any ANDA for generic dronabinol oral solution that cites Syndros as the reference-listed drug if it relies on a waiver in lieu of establishing *in vivo* bioequivalence to Syndros and to require that ANDA applicants for generic Syndros include fed and fasted state bioequivalence studies.

The agency denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-6411-0010&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says the company argued that fed and fasting bioequivalence studies are required due to the drug’s complexity and directions for use of the product with food. The company also said that a waiver is inappropriate because metabolite equivalence should be measured in addition to parent drug equivalence.

The agency says it disagrees with the company’s assertions about the need for bioequivalence tests and the lack of suitability of a waiver. FDA also noted that it would not decline to receive any ANDA relying upon a waiver because during its initial assessment of an ANDA, it does not evaluate the sufficiency of specific data or information submitted by the applicant to satisfy a requirement for approval such as bioequivalence.