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# FDA Approves 9 ANDAs for Generic Lyrica
- URL: https://www.fdaweb.com/fda-approves-9-andas-for-generic-lyrica/
- Published: 2019-07-22T12:00:00.000Z
- Updated: 2026-09-15T01:39:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144580

FDA has approved nine ANDAs for first generics of Pfizer’s Lyrica (pregabalin) for managing neuropathic pain associated with diabetic peripheral neuropathy, and for managing postherpetic neuralgia. The generics are also indicated as adjunctive therapy for treating partial onset seizures in patients 17 years of age and older, for managing fibromyalgia and neuropathic pain associated with spinal cord injury. Approvals were granted to Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy's Laboratories, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals, Sciegen Pharmaceuticals and Teva Pharmaceuticals.

The approvals require that the drugs be dispensed with a patient Medication Guide that contains information about its uses and risks, an [FDA release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-generics-lyrica?ref=fdaweb.com) says. “Warnings include the risk of angioedema (swelling of the throat, head and neck), which may be associated with life-threatening respiratory compromise requiring emergency treatment. Hypersensitivity reactions such as hives, dyspnea (difficulty breathing) and wheezing can occur. Increased seizure frequency or other adverse reactions may occur if the drug is rapidly discontinued.”