FDA Approves Generic Versions of Lyrica

Article

Several new generics available to treat neuropathic pain linked to diabetic peripheral neuropathy, fibromyalgia partial onset seizures, and other conditions.

FDA

Several generic versions of pregabalin (Lyrica) will soon be on the market to help manage neuropathic pain associated with diabetic peripheral neuropathy.

The US Food and Drug Administration (FDA) approved multiple applications of the pain management drug to a group of manufacturers including Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy's Laboratories, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals, Sciegen Pharmaceuticals, and Teva Pharmaceuticals.

Along with managing pain linked to diabetic peripheral neuropathy, the drug also manages postherpetic neuralgia, treat partial onset seizures in patients older than 17 as an adjunctive therapy, manages fibromyalgia, and manages neuropathic pain associated with spinal cord injuries.

Pregabalin comes with several warnings and risks, including the risk of peripheral edema and angioedema, which can cause a life-threatening respiratory condition.

Hypersensitivity reactions including hives, dyspnea and wheezing, dizziness and drowsiness can occur when taking the medication.

There are also adverse reactions should the patient rapidly discontinue use of the drug, including increased seizure frequency. In clinical trials, participants reported dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain, and abnormal thinking.

Antiepileptic drugs in general have been found to increase the risk of suicidal thoughts or behavior.

The new generics are part of the FDA’s Drug Competition Action Plan to address the challenges related to developing generics, while promoting more generic competition to allow patient’s greater access to more affordable medicines.

"The FDA requires that generic drugs meet rigorous scientific and quality standards,” Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statement regarding the approval. “Efficiently bringing safe and effective generics to market so patients have more options to treat their conditions is a top priority for the FDA.”

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