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FDA Grants First Approvals for Generic Versions of Lyrica

TUESDAY, July 23, 2019 -- Nine drug companies have received approval for the first generic versions of Lyrica (pregabalin), the U.S. Food and Drug Administration announced.

The generic versions of Lyrica have been approved to manage neuropathic pain from diabetic peripheral neuropathy or spinal cord injury, postherpetic neuralgia, and fibromyalgia. The agency also approved the generic versions as adjunctive therapy for partial onset seizures in patients aged 17 years and older.

The FDA noted that pregabalin must be dispensed with a patient medication guide. Pregabalin carries the risks for angioedema, hypersensitivity reactions, dyspnea, and wheezing. If patients rapidly discontinue using the drug, they could experience increased seizure frequency or other adverse reactions. As with other antiepileptic drugs, pregabalin could increase the risk for suicidal thoughts or behavior. It could also cause peripheral edema, and providers should be cautious when prescribing pregabalin with thiazolidinedione antidiabetic agents. The most commonly reported side effects of pregabalin include dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain, and difficulty concentrating or paying attention.

Approvals for the generic versions of Lyrica were granted to Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy's Laboratories, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals, Sciegen Pharmaceuticals, and Teva Pharmaceuticals.

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Posted: July 2019

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