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# Insys Wants Generic Syndros Requirements
- URL: https://www.fdaweb.com/insys-wants-generic-syndros-requirements/
- Published: 2017-11-09T12:00:00.000Z
- Updated: 2026-09-14T23:01:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140095

Insys Therapeutics is [petitioning](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-6411-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) FDA to not approve any ANDA referencing its Syndros (dronabinol) oral solution if the ANDA relies on an agency waiver of bioequivalence studies. The petition also asks FDA to require ANDA applicants for generic Syndros to include fed and fasted state bioequivalence studies.

“Insys is concerned that FDA has permitted and may continue to permit waivers of bioequivalence testing for products referencing its NDA,” the company says. “Syndros has inherent product characteristics that may affect bioequivalence. To ensure required product safety and efficacy, Insys requests that FDA require generic applicants to conduct and submit in their ANDAs bioequivalence studies in both the fed and fasted state.”

Dronabinol is described as a cannabinoid indicated for treating anorexia associated with weight loss in AIDS patients and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

The company says it is awaiting an FDA exclusivity determination on Syndros and anticipates receiving three years of exclusivity based on the submission of new clinical studies essential to approval.

The petition asks the agency to refuse to approve a Par ANDA and refuse to receive or approve any other ANDA for generic Syndros based on waivers of bioequivalence. “In the absence of rigorous requirements for approval, a proposed generic dronabinol oral solution may fail to demonstrate bioequivalence to Syndros,” the company concludes, “putting cancer and AIDS patients at risk of receiving an unsafe or ineffective product.”