Manages neuropathic pain associated with diabetic peripheral neuropathy. ANDA 207623, held by Alkem Labs Ltd. Pregabalin.
As of Nov 14, 2026, ANDA 207623 (Pregabalin), held by Alkem Labs Ltd, was first approved by FDA on Jul 19, 2019, 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 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 1 month of age and older Fibromyalgia Neuropathic pain associated with spinal cord injury
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 19, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pregabalin20MG/ML · solution;oral | Pregabalin | Rx |
| Feb 23, 2026 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 26, 2023 | Supplement 1Labeling · 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
