Lyrica
Generic name: pregabalin
Treatment for: Neuropathic Pain, Postherpetic Neuralgia, Fibromyalgia, Diabetic Peripheral Neuropathy, Epilepsy
Pfizer Statement on Regulatory Status of Lyrica
NEW YORK, September 02, 2004 -- In response to media inquiries, Pfizer said it has received approvable letters from the US Food & Drug Administration for three indications for Lyrica (pregabalin): neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, and as adjunctive therapy in the treatment of partial seizures in adults. Pfizer received a non-approvable letter for Lyrica for the treatment of generalized anxiety disorder.
Pfizer said it is continuing to work closely with the FDA during the ongoing regulatory review to resolve open issues on all indications and labeling.
In the European Union, Lyrica received marketing approval in July 2004 for the management of peripheral neuropathic pain and as an adjunctive therapy in the treatment of partial seizures.
For further information, please visit www.pfizer.com
Posted: September 2004
Related articles
- FDA Approves Lyrica CR (pregabalin) Extended-Release Tablets for Neuropathic Pain Conditions - October 12, 2017
- FDA Approves Lyrica For The Management Of Neuropathic Pain Associated With Spinal Cord Injury Based On Priority Review - June 21, 2012
- FDA Approves First Drug for Treating Fibromyalgia - Lyrica - June 22, 2007
- Lyrica Pfizer Inc. - Treatment for Neuropathic Pain - December 31, 2004
Lyrica (pregabalin) FDA Approval History
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
