Lyrica adds third indication
Executive Summary
Pfizer's Lyrica (pregabalin) clears FDA June 10 for treatment of partial onset seizures. The Neurontin follow-on was approved for diabetic peripheral neuropathy and postherpetic neuralgia in December 2004 (1"The Pink Sheet" Jan. 10, 2005, p. 5). Lyrica's launch is awaiting final Drug Enforcement Agency scheduling. Pfizer says pregabalin will be available in pharmacies in the fall...
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Lyrica launch
Pfizer's Neurontin follow-on Lyrica is now available in pharmacies, the drug maker announces Sept. 21. Availability of pregabalin comes nine months after FDA's initial approval and almost a year after the launch of Neurontin (gabapentin) generics. FDA approved Lyrica in December for treatment of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia; the product added an indication in June for adjunctive treatment of partial onset seizures in adults (1"The Pink Sheet" June 20, 2005, p. 25). The Schedule V controlled substance completed Drug Enforcement Administration scheduling in July, but its launch was stalled pending production of packaging including the controlled substance information, according to Pfizer....
Lyrica is a Schedule V controlled substance
Pfizer plans to launch Lyrica (pregabalin) in the fall following DEA's July 28 final rule classifying the drug as a Schedule V controlled substance. Launch of the gabapentin follow-on has been delayed by the scheduling process. FDA cleared pregabalin in December for neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia; Lyrica added an indication for partial onset seizures in June (1"The Pink Sheet" June 20, 2005, In Brief)...
Pfizer Lyrica Launch Awaits Controlled Substance Scheduling
Pfizer's launch of Lyrica will be delayed while pregabalin undergoes controlled substance scheduling at the Drug Enforcement Administration