FDA grants approvals for generic Lyrica

The US Food and Drug Administration (US FDA) has approved multiple applications for first generics of Lyrica (pregabalin) for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia. It also acts as an adjunctive therapy for the treatment of partial onset seizures in patients aged 17 years and above for fibromyalgia and neuropathic pain associated with spinal cord injury.

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

“The FDA requires that generic drugs meet rigorous scientific and quality standards. This approval of the first generics for pregabalin is another example of the FDA’s longstanding commitment to advance patient access to lower cost, high-quality generic medicines,” said Janet Woodcock, MD — Director of the FDA’s Center for Drug Evaluation and Research.

“Efficiently bringing safe and effective generics to market so patients have more options to treat their conditions is a top priority for the FDA,” Woodcock added.

Pregabalin must be dispensed with a patient medication guide that contains important information about its uses and risks. Warnings include the risk of angioedema (swelling of the throat, head and neck), which may be associated with life-threatening respiratory compromise requiring emergency treatment. Hypersensitivity reactions such as hives, dyspnea (difficulty in breathing) and wheezing can occur. Increased seizure frequency or other adverse reactions may occur if the drug is rapidly discontinued. Anti-epileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behaviour. Additionally, pregabalin may cause peripheral edema (swelling of hands or legs). So, caution should be exercised when co-administering it with thiazolidinedione antidiabetic agents. Pregabalin may cause dizziness and drowsiness and impair ability to drive or operate machinery.

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).

Addressing the challenges related to developing generics and promoting more generic competition is a key part of the Drug Competition Action Plan and the agency’s efforts to help advance patient access to more affordable medicines.