Lyrica

Manages neuropathic pain associated with diabetic peripheral neuropathy. NDA 21446, held by Upjohn. Pregabalin.

As of Nov 14, 2026, NDA 21446 (Lyrica), held by Upjohn, was first approved by FDA on Dec 30, 2004, with 22 approved supplements and 0 published complete response letters.

First approved: Dec 30, 2004
Review: Priority
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

LYRICA 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 LYRICA 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

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


May 23, 2019	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Label Letter
May 3, 2018	Supplement 35Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 22, 2016	Supplement 32Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Jun 20, 2012	Supplement 28Efficacy (new indication or use) · Priority review	Approved	Review Summary Review Letter Label
Jun 21, 2007	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 30, 2004	Original applicationNew molecular entity · Priority review	Approved	Review Letter

Products

8 strengths and forms


Lyrica25MG · capsule;oral	Pregabalin	RxReference drug
Lyrica50MG · capsule;oral	Pregabalin	RxReference drug
Lyrica75MG · capsule;oral	Pregabalin	RxReference drug
Lyrica100MG · capsule;oral	Pregabalin	RxReference drug
Lyrica150MG · capsule;oral	Pregabalin	RxReference drug
Lyrica200MG · capsule;oral	Pregabalin	RxReference drug
Lyrica225MG · capsule;oral	Pregabalin	RxReference drug
Lyrica300MG · capsule;oral	Pregabalin	RxReference drug

All 23 submissions, including labeling and manufacturing supplements


Apr 25, 2025	Supplement 46Labeling · Standard review	Approved	Letter Label Medication Guide
Dec 13, 2023	Supplement 41Labeling · Standard review	Approved	Label Letter
Apr 3, 2020	Supplement 40Labeling · Standard review	Approved	Label Letter
May 23, 2019	Supplement 36Efficacy (new indication or use) · Priority review	Approved	Label Letter
May 3, 2018	Supplement 35Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 22, 2016	Supplement 32Efficacy (new indication or use) · Standard review	Approved	Letter Label Pediatric Medical Review Pediatric Clinical Pharmacology Review
Jul 8, 2016	Supplement 31Manufacturing · Priority review	Approved	None posted
Mar 9, 2016	Supplement 30Labeling · Standard review	Approved	Label Letter
Dec 23, 2013	Supplement 29Labeling · Standard review	Approved	Letter Label
Jun 20, 2012	Supplement 28Efficacy (new indication or use) · Priority review	Approved	Review Summary Review Letter Label
Aug 24, 2011	Supplement 25Labeling	Approved	Label Letter
Jun 20, 2011	Supplement 26Labeling · Standard review	Approved	Label Letter
Apr 26, 2011	Supplement 24REMS	Approved	Label Letter
Apr 26, 2011	Supplement 23Labeling	Approved	Letter Label
Oct 8, 2010	Supplement 21Labeling	Approved	Label Letter
Jan 4, 2010	Supplement 18Labeling	Approved	Label Letter
Apr 23, 2009	Supplement 14Labeling · Standard review	Approved	Label Letter
Apr 23, 2009	Supplement 13Labeling	Approved	Label Letter
Jun 21, 2007	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 27, 2006	Supplement 6Labeling · Standard review	Approved	Letter
Feb 17, 2006	Supplement 3Labeling · Standard review	Approved	Letter Label
Feb 17, 2006	Supplement 2Labeling · Standard review	Approved	Letter Label
Dec 30, 2004	Original applicationNew molecular entity · Priority review	Approved	Review Letter

Identifiers

Application: NDA 21446
Drugs@FDA: Overview at FDA
Company: Upjohn

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