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Multiple Applications Approved for First Lyrica Generics
The FDA has approved a number of applications for the first generic versions of Lyrica (pregabalin) for the management of neuropathic pain caused by diabetic peripheral neuropathy; for the management of postherpetic neuralgia; as adjunctive therapy for partial-onset seizures in patients aged 17 years and older; for the management of fibromyalgia; and for the management of neuropathic pain associated with spinal cord injury.
Pregabalin must be dispensed with a patient Medication Guide. Warnings include the risk of angioedema, which can be associated with life-threatening respiratory compromise requiring emergency treatment. Hypersensitivity reactions including hives, dyspnea, and wheezing can occur. Increased seizure frequency or other adverse reactions may occur if pregabalin is rapidly discontinued. Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior. In addition, pregabalin can cause peripheral edema, and caution should be exercised when co-administering it with thiazolidinedione antidiabetic agents. Pregabalin may also cause dizziness and drowsiness and impair one’s ability to drive or operate machinery.
The most common side effects reported in clinical trials for Lyrica in adults are dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain, and abnormal thinking (difficulty with concentration/attention).
The 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.
Source: FDA, July 22, 2019