The capsule is named for GABA. The binding line is not.
Gabapentin is structurally related to the neurotransmitter gamma-aminobutyric acid (GABA) but has no effect on GABA binding, uptake, or degradation. In vitro studies have shown that gabapentin binds with high affinity to the alpha-2-delta subunit of voltage-activated calcium channels. The same paragraph says the relationship of this binding to the therapeutic effects of gabapentin is unknown. A history that ends with a GABA-boost slogan has stopped before the sentence that retires that story. The name stayed. The assay did not agree with the name.
The current label is the April 2025 Neurontin prescribing information on DailyMed, held by Viatris. It still uses that mechanism wording. It does not name a year for the binding discovery, so this note does not invent one.
December 1993 was an add-on seizure approval
The label's own line is only the year: Initial U.S. Approval: 1993. The month is in the Justice Department release of Thursday, 13 May 2004. That release says the drug Neurontin was approved by the Food and Drug Administration in December 1993 solely for adjunctive or supplemental anti-seizure use by epilepsy patients. Neurontin was launched into the marketplace in February of 1994. Parke-Davis is the Warner-Lambert division named in the release. A public drug card that only prints 1993 matches the year on the label. It does not supply the month or the adjunctive-only limit. Those two details come from the 2004 Justice Department release.
Adjunctive means the capsule was added to other seizure drugs. The same release says Warner-Lambert later promoted Neurontin as a first-line monotherapy, using it alone, even after solo use had been specifically rejected by the FDA. A timeline that treats the 1993 stamp as permission to use the drug by itself for epilepsy is reading a later sales plan back onto the original approval.
What the 13 May 2004 plea actually priced
Warner-Lambert agreed to plead guilty and pay more than $430 million to resolve criminal charges and civil liabilities in connection with illegal and fraudulent promotion of unapproved uses. The criminal punishment in the agreement was a $240 million fine. The release is a charging and settlement document. It is not a new clinical trial, and it is not a recall of the 1993 approval.
The uses named as promoted beyond that approval include bipolar mental disorder, various pain disorders, ALS, attention deficit disorder, migraine, drug and alcohol withdrawal seizures, restless leg syndrome, and monotherapy for epilepsy. One example in the release is bipolar disease: the company promoted Neurontin even when a scientific study demonstrated that a placebo worked as well or better than the drug. Another is the monotherapy push after FDA had rejected solo use. The tactics listed are sales pitches without a doctor asking first, medical liaisons, paid consultant meetings, teleconferences, company-shaped continuing education, and representatives in the exam room. This note does not restage those dinners. The point for a reader is narrower: the growth in off-label prescriptions was a marketing project the company later pleaded to, not a second FDA indication.
Pfizer acquired Warner-Lambert in June 2000. The release says the charged conduct occurred prior to the acquisition. A history that pins the plea on the company that owns the brand today is skipping that sentence.
The same release gives one Veterans Affairs sales pair: Neurontin sales to the Department of Veterans Affairs went from $287,000 to $43.2 million between 1994 and 2002, and the department said those sales in part reflect the illegal marketing. That is a sales figure, not a count of patients who were harmed, and not a measure of whether a later labeled use works.
The current label lists a job the 1993 approval did not
The April 2025 label indicates Neurontin for management of postherpetic neuralgia in adults and, separately, as adjunctive therapy for partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy. This history note does not date the nerve-pain addition. The 2004 release describes the original approval as adjunctive seizures. The current label prints the nerve-pain line and does not print the year that line was added. Guessing a year because older web pages do would be a date this file does not hold.
The plea also does not erase the two lines that are on the label now. A settlement about promotion past an approval is not a finding that the later nerve-pain trials failed, and it is not a finding that add-on seizure use was withdrawn. Those trial numbers live on the evidence note, not in this timeline.
What to do with a Neurontin timeline
If the question is when the drug was first approved in the United States, the sourced answer is December 1993 for add-on seizures, with a market launch in February 1994, and a label that still prints 1993. If the question is why the name says GABA, the sourced answer is structural kinship plus a binding line at the alpha-2-delta subunit, with the effect of that binding left unknown. If the question is the lawsuit, the sourced answer is the 13 May 2004 agreement: more than $430 million, including a $240 million criminal fine, over off-label promotion by Warner-Lambert's Parke-Davis division, with the charged conduct dated before Pfizer's June 2000 acquisition.
The milligram table, including the creatinine-clearance rows, is on the gabapentin 300 mg dosing note. The placebo columns for the labeled trials are on the gabapentin evidence note. The medicine page is Neurontin. The mechanism sentences were read from the Neurontin label on DailyMed. The December 1993 limit, the February 1994 launch, and the dollar figures were read from the Justice Department release of 13 May 2004.
Reviewed against the Neurontin prescribing information on DailyMed and the Department of Justice release of 13 May 2004, on 24 October 2026.