US FDA approves first generic Lyrica for mutliple indications
23 July 2019 -

Public health agency the US Food and Drug Administration announced on Monday that it has awarded marketing approval for multiple applications for first generics of Lyrica (pregabalin) for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy for the partial onset seizures in patients 17 years of age and older, fibromyalgia and neuropathic pain associated with spinal cord injury.

The US FDA granted approvals for the generic versions of Lyrica to Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy's Laboratories, InvaGen Pharmaceuticals, MSN Laboratories Ltd, Rising Pharmaceuticals Inc, Sciegen Pharmaceuticals Inc and Teva Pharmaceuticals.

According to the US FDA, pregabalin must be dispensed with a patient Medication Guide that contains important information about its uses and risks.

According to the agency, the most common side effects reported in the clinical trials for Lyrica in adults are dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain and abnormal thinking (primarily difficulty with concentration/attention).