Manages neuropathic pain associated with diabetic peripheral neuropathy. ANDA 205321, held by Aurobindo Pharma. Pregabalin.
As of Nov 13, 2026, ANDA 205321 (Pregabalin), held by Aurobindo Pharma, was first approved by FDA on Mar 29, 2023, with 2 approved supplements and 0 published complete response letters.
Pregabalin capsules are 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 29, 2023 | 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 |
| Jun 23, 2026 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 5, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 29, 2023 | 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
