FDA — authorised 19 July 2019
- Application: ANDA207623
- Marketing authorisation holder: ALKEM LABS LTD
- Status: approved
🇺🇸 Lyrica in United States
FDA authorised Lyrica on 19 July 2019 · 120,754 US adverse-event reports
Marketing authorisations
FDA — authorised 18 February 2022
- Application: ANDA212604
- Marketing authorisation holder: PATRIN
- Status: approved
FDA — authorised 29 March 2023
- Application: ANDA205321
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
FDA — authorised 12 July 2023
- Application: ANDA206452
- Marketing authorisation holder: CADILA PHARMS LTD
- Status: approved
FDA — authorised 24 February 2026
- Application: ANDA218529
- Marketing authorisation holder: FOURRTS LABS
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 120,754
Most-reported reactions
- Pain — 21,922 reports (18.15%)
- Drug Ineffective — 20,076 reports (16.63%)
- Dizziness — 11,118 reports (9.21%)
- Fatigue — 10,736 reports (8.89%)
- Malaise — 10,043 reports (8.32%)
- Nausea — 10,034 reports (8.31%)
- Weight Increased — 9,901 reports (8.2%)
- Pain In Extremity — 9,160 reports (7.59%)
- Headache — 9,023 reports (7.47%)
- Off Label Use — 8,741 reports (7.24%)
Lyrica in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Lyrica approved in United States?
Yes. FDA authorised it on 19 July 2019; FDA authorised it on 18 February 2022; FDA authorised it on 29 March 2023.
Who is the marketing authorisation holder for Lyrica in United States?
ALKEM LABS LTD holds the US marketing authorisation.