Lyrica Controlled Substance Scheduling Finalized By DEA
This article was originally published in The Pink Sheet Daily
Pfizer’s pregabalin will launch in the fall for three indications as a Schedule V controlled substance.
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Pfizer announces approval of the third indication for Lyrica (pregabalin) on the same day that comments are due on the Drug Enforcement Agency’s proposed scheduling for the product. The Neurontin follow-on will launch with three out of four original indications.
The pregabalin launch is at least a month away following the Drug Enforcement Administration’s proposed rule on controlled substance scheduling for the neuropathic pain agent. Lyrica has a “low potential for abuse” relative to Schedule IV substances, DEA says.
The company received a "non-approvable" letter for the treatment of generalized anxiety disorder. Pfizer says it is working with FDA to resolve "open issues on all indications" for the Neurontin follow-on agent.