FDA Authorized Multiple Applications for First Generics of Lyrica

U.S. Food and Drug Administration authorized multiple applications for first generics of Lyrica (pregabalin) for the management of neuropathic pain related to diabetic peripheral neuropathy, for the management of postherpetic neuralgia, as an adjunctive remedy for the treatment of partial-onset seizures in patients 17 years of age and older, for the management of fibromyalgia, and neuropathic pain related to spinal cord injury.

Pregabalin must be dispensed with a patient Medication Guide that contains essential information about it makes use of and risks. Warnings embody the risk of angioedema (swelling of the throat, head, and neck), which can be related to life-threatening respiratory compromise requiring emergency treatment. Hypersensitivity reactions akin to hives, dyspnea (difficulty breathing) and wheezing can occur. Elevated seizure frequency or different opposed reactions might happen if the drug is quickly discontinued. Antiepileptic drugs, together with pregabalin, enhance the risk of suicidal ideas or conduct. Moreover, pregabalin might trigger peripheral edema (swelling of hands or legs), so warning must be exercised when co-administering it with thiazolidinedione antidiabetic brokers. Pregabalin might cause dizziness and drowsiness and impair the ability to drive or operate machinery.

The most common side effects reported within 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).

The FDA granted approvals for the generic variations 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.

Addressing the challenges associated with developing generics and promoting more generic competitors is a crucial part of the Drug Competition Action Plan and the agency’s efforts to assist advance patient entry to more affordable medicines.

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