Nine generic firms get FDA approval for generic Lyrica
The Food and Drug Administration has approved multiple applications for first generics of Pfizer's Lyrica (pregabalin).
Following on the heels of news that the FDA gave its approval to Amneal, the FDA announced that the following companies also received clearance for generic Lyrica: Alembic, Alkem, Dr. Reddy's, InvaGen, MSN Laboratories, Rising Pharmaceuticals, Sciegen, and Teva.
The product is used for the management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, as an adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury.
"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," said Janet Woodcock, director of the FDA's center for drug evaluation and research.
Amneal president and CEO Rob Stewart said, “This new generic launch provides an important treatment option for patients and, as our 21st generic product launch this year, demonstrates the continued momentum of our generic pipeline. We expect this momentum to continue throughout the remainder of 2019 as we work toward making up to 50 new generic products available to patients in the U.S.”
Pregabalin capsules had a market value of about $5.4 billion for the 12 months ended May 31, 2019, according to IQVIA.
Following on the heels of news that the FDA gave its approval to Amneal, the FDA announced that the following companies also received clearance for generic Lyrica: Alembic, Alkem, Dr. Reddy's, InvaGen, MSN Laboratories, Rising Pharmaceuticals, Sciegen, and Teva.
The product is used for the management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, as an adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury.
"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," said Janet Woodcock, director of the FDA's center for drug evaluation and research.
Amneal president and CEO Rob Stewart said, “This new generic launch provides an important treatment option for patients and, as our 21st generic product launch this year, demonstrates the continued momentum of our generic pipeline. We expect this momentum to continue throughout the remainder of 2019 as we work toward making up to 50 new generic products available to patients in the U.S.”
Pregabalin capsules had a market value of about $5.4 billion for the 12 months ended May 31, 2019, according to IQVIA.