Pregabalin

Manages neuropathic pain associated with diabetic peripheral neuropathy. ANDA 203459, held by Alembic. Pregabalin.

As of Nov 13, 2026, ANDA 203459 (Pregabalin), held by Alembic, was first approved by FDA on Jul 19, 2019, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 19, 2019
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Pregabalin capsule 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 17 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 19, 2019	Original application	Approved	None posted

Products

8 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Jul 21, 2025	Supplement 16Labeling · Standard review	Approved	None posted
Aug 28, 2024	Supplement 14Labeling · Standard review	Approved	None posted
Jun 9, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Jul 19, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 203459
Drugs@FDA: Overview at FDA
Company: Alembic, LLC

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