Manages neuropathic pain associated with diabetic peripheral neuropathy. ANDA 212604, held by Anda Repository. Pregabalin.
As of Nov 13, 2026, ANDA 212604 (Pregabalin), held by Anda Repository, was first approved by FDA on Feb 18, 2022, with 0 approved supplements and 0 published complete response letters.
Pregabalin oral solution 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 4 years of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury Pediatric use information is approved for Pfizer's LYRICA (pregabalin) Capsules and Oral Solution products. However, due to Pfizer's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 18, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pregabalin20MG/ML · solution;oral | Pregabalin | Rx |
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
