Manages neuropathic pain associated with diabetic peripheral neuropathy. ANDA 205924, held by Macleods Pharms. Pregabalin.
As of Nov 13, 2026, ANDA 205924 (Pregabalin), held by Macleods Pharms, was first approved by FDA on Nov 12, 2024, with 1 approved supplement 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 |
|---|---|---|---|
| Nov 12, 2024 | Original application | Approved | None posted |
| Pregabalin25MG · capsule;oral | Pregabalin | Discontinued |
| Pregabalin50MG · capsule;oral | Pregabalin | Discontinued |
| Pregabalin75MG · capsule;oral | Pregabalin | Discontinued |
| Pregabalin100MG · capsule;oral | Pregabalin | Discontinued |
| Pregabalin150MG · capsule;oral | Pregabalin | Discontinued |
| Pregabalin200MG · capsule;oral | Pregabalin | Discontinued |
| Pregabalin225MG · capsule;oral | Pregabalin | Discontinued |
| Pregabalin300MG · capsule;oral | Pregabalin | Discontinued |
| Jul 21, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 12, 2024 | 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
