Manages neuropathic pain associated with diabetic peripheral neuropathy. ANDA 206452, held by Cadila Pharms Ltd. Pregabalin.
As of Nov 13, 2026, ANDA 206452 (Pregabalin), held by Cadila Pharms Ltd, was first approved by FDA on Jul 12, 2023, 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 |
|---|---|---|---|
| Jul 12, 2023 | 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 |
| Apr 30, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 12, 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
