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Draft Guidance on Gabapentin October 2024 This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It...
Gabapentin, sold under the brand name Neurontin among others, is an anticonvulsant medication primarily used to treat neuropathic pain and also for partial seizures [10][7] of epilepsy. It is a …
The effectiveness of gabapentin as adjunctive therapy (added to other antiepileptic drugs) was established in multicenter placebo-controlled, double-blind, parallel-group clinical trials in adult …
Detailed FDA approval information for Gabapentin including labelers, registrants, and establishments
Gabapentin is a prescription medication approved by the United States Food and Drug Administration (FDA) for the treatment of neuropathic pain and epileptic disorders. This drug is …
Mar 29, 2022 · Detailed FDA approval information for Gabapentin, including regulatory status, product details, and official drug labeling information.
In December 1993, the US Food and Drug Administration (FDA) granted approval for gabapentin, under the brand name Neurontin, for adjunctive therapy of partial seizures.
Therefore, the Petitioner requests that FDA find that a change in capsule strength to 450 mg, 600 mg, and 800 mg of gabapentin raises no questions of safety or effectiveness.
Driving performance studies conducted with a prodrug of gabapentin (gabapentin enacarbil tablet, extended-release) indicate that gabapentin may cause significant driving impairment.
Nov 29, 2002 · Dear Ms. McIntyre: Please refer to your supplemental new drug applications (sNDAs) dated and received June 16, 2020, and your amendments, submitted under section …
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