Manages neuropathic pain associated with diabetic peripheral neuropathy. ANDA 212865, held by Chartwell Rx. Pregabalin.
As of Nov 13, 2026, ANDA 212865 (Pregabalin), held by Chartwell Rx, was first approved by FDA on Mar 20, 2020, with 2 approved supplements and 0 published complete response letters.
Pregabalin 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 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury Pregabalin Capsules are indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) Postherpetic neuralgia (PHN) Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Fibromyalgia Neuropathic pain associated with spinal cord injury
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 20, 2020 | Original application | Approved | None posted |
| Pregabalin50MG · capsule;oral | Pregabalin | Rx |
| Pregabalin75MG · capsule;oral | Pregabalin | Rx |
| Pregabalin100MG · capsule;oral | Pregabalin | Rx |
| Pregabalin150MG · capsule;oral | Pregabalin | Rx |
| Dec 23, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 23, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 20, 2020 | 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
