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# TerSera Wants Prialt ANDA Conditions
- URL: https://www.fdaweb.com/tersera-wants-prialt-anda-conditions/
- Published: 2025-01-28T12:00:00.000Z
- Updated: 2026-09-14T14:51:48.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5158560

TerSera Therapeutics is petitioning FDA to require that ANDAs citing the company’s Prialt (ziconotide) as the reference-listed drug/device combination to meet compatibility testing requirements to support product labeling for use with the Medtronic SynchroMed II and SynchroMed III infusion system. The company’s [petition](https://downloads.regulations.gov/FDA-2025-P-0334-0001/attachment%5F1.pdf?ref=fdaweb.com) says Prialt is indicated to manage severe chronic pain in patients for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatments. Prialt’s labeling specifically identifies the two Medtronic systems, it says.

The petition says FDA required TerSera to perform compatibility testing to assess the effects of dilution, adsorption, and degradation of the drug in the pump. The agency also is requiring the company to conduct periodic testing to monitor continued compatibility with the Medtronic pump, it says.

“The compatibility testing is critical to support the labeling of Prialt for use with the Medtronic pump and to monitor product quality and safety,” TerSera says. “Another manufacturer’s ziconotide product, intended as the drug constituent part of the drug-device combination product, must establish that it is compatible with the Medtronic pump.”