is Gabapentin approved by the U.S. Food and Drug Administration (FDA) ?

Gabapentin was originally approved by the U.S. Food and Drug Administration (FDA) in December 1993, for use as an adjuvant medication to control partial seizures (effective when added to other antiseizure drugs) in adults; that indication was extended to children in 2000. In 2004, its use for treating postherpetic neuralgia (neuropathic pain following shingles) was approved

Gabapentin is best known under the brand name Neurontin manufactured by Pfizer subsidiary Parke-Davis. A Pfizer subsidiary named Greenstone markets generic gabapentin.

In December 2004 the FDA granted final approval to a generic equivalent to Neurontin made by the Israeli firm Teva.

Neurontin began as one of Pfizer’s best selling drugs; however, Pfizer has come under heavy criticism and serious litigation for its marketing of the drug. They face allegations that, behind the scenes, Parke-Davis marketed the drug for at least a dozen supposed uses that the FDA had not approved. Today it is a mainstay drug for migraines, even though it was not approved for such use in 2004.

 

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