Manages neuropathic pain associated with diabetic peripheral neuropathy. ANDA 209357, held by Msn. Pregabalin.
As of Nov 13, 2026, ANDA 209357 (Pregabalin), held by Msn, was first approved by FDA on Jul 19, 2019, with 3 approved supplements and 0 published complete response letters.
Pregabalin capsule is indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury Pregabalin capsule is indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) Postherpetic neuralgia (PHN) Adjunctive therapy for the treatment of partial onset seizures in patients 1month of age and older Fibromyalgia Neuropathic pain associated with spinal cord injury
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 19, 2019 | Original application | Approved | None posted |
| Pregabalin25MG · capsule;oral | Pregabalin | Rx |
| Pregabalin50MG · capsule;oral | Pregabalin | Rx |
| Pregabalin75MG · capsule;oral | Pregabalin | Rx |
| Pregabalin100MG · capsule;oral | Pregabalin | Rx |
| Pregabalin150MG · capsule;oral | Pregabalin | Rx |
| Pregabalin200MG · capsule;oral | Pregabalin | Rx |
| Pregabalin225MG · capsule;oral | Pregabalin | Rx |
| Pregabalin300MG · capsule;oral | Pregabalin | Rx |
| Jul 14, 2026 | Supplement 14Labeling · Standard review | Approved | None posted |
| Jun 9, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 9, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jul 19, 2019 | Original application | Approved | None posted |
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
