FDA Approves Generic Pregabalin Capsules to Treat Fibromyalgia, Chronic Pain Conditions

FDA Approves Generic Pregabalin Capsules to Treat Fibromyalgia, Chronic Pain Conditions
The U.S. Food and Drug Administration (FDA) has approved generic pregabalin capsules for the treatment of fibromyalgia and other medical conditions associated with chronic pain. The FDA granted the approvals to Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy's Laboratories, InvaGen Pharmaceuticals, MSN Laboratories Ltd., Rising Pharmaceuticals, Sciegen Pharmaceuticals, and Teva Pharmaceuticals. Pregabalin is the AB generic equivalent to Pfizer's Lyrica, an anti-epileptic drug (anticonvulsant) that has been approved by the FDA for the treatment of fibromyalgia and neuropathic (nerve) pain associated with diabetes (diabetic neuropathy), herpes zoster (post-herpetic neuralgia), or spinal cord injury. The medication works by slowing the propagation of electrical signals in the brain that causes seizures, which is also the reason why pregabalin is sometimes used together with other treatments to control seizures in adults and children. It also works by affecting the operation of certain brain chemicals associated with pain signals. An AB generic is a medication that has been shown to be equivalent, from a biological and biochemical standpoint, to the brand-name product in preclinical studies. It is the most common designation among generic medications. "Today’s approval of the first generics for pregabalin, a widely-used medication, is another example of the FDA’s longstanding commitment to advance patient access to lower cost, high-quality generic medicines," Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. "The FDA requires that generic drugs meet rigorous scientific and quality standards. Efficiently bringing safe and effective generics to market so pati
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