Manages intractable chronic pain severe enough to require an opioid analgesic. ANDA 204393, held by Piramal Critical. Morphine Sulfate.
As of Nov 15, 2026, ANDA 204393 (Mitigo), held by Piramal Critical, was first approved by FDA on Jul 16, 2018, with 3 approved supplements and 0 published complete response letters.
MITIGO is for use in continuous microinfusion devices and indicated only for intrathecal or epidural infusion in the management of intractable chronic pain severe enough to require an opioid analgesic and for which less invasive means of controlling pain are inadequate. Limitations of Use Not for single-dose intravenous, intramuscular, or subcutaneous administration due to the risk of overdose. Not for single-dose neuraxial injection because MITIGO is too concentrated for accurate delivery of the smaller doses used in this setting.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 16, 2018 | Original application | Approved |
| Mitigo10MG/ML · injectable;injection | Morphine Sulfate | Rx |
| Mitigo25MG/ML · injectable;injection | Morphine Sulfate | Rx |
| Nov 2, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 24, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 6, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 16, 2018 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
