Appendix 1.
Timeline of events pertaining to the use of gabapentin for bipolar disorder
| Month and Year | Event |
|---|---|
| May, 1977 | U.S. Patent granted to Warner-Lambert for gabapentin |
| December, 1993 | Gabapentin is FDA-approved for adjunctive treatment of partial complex seizures in individuals over 12 years old |
| June, 1995 | Depakote, an anticonvulsant drug, is approved to treat bipolar mania |
| August, 1996 | Lawsuit filed by a former Parke-Davis employee against Warner-Lambert for illegal marketing of gabapentin for off-label uses |
| December, 1999 | Seal on above lawsuit is lifted and litigation resumes. |
| June, 2000 | Pfizer acquires Warner-Lambert and its marketing division Parke-Davis |
| Sept, 2000 | Publication of 1st RCT that showed that gabapentin had no efficacy in the treatment of BPD |
| October, 2000 | Gabapentin is FDA-approved for adjunctive treatment of partial seizures in patients ages 3–12 years old. |
| December, 2000 | Publication of 2nd RCT that showed that gabapentin had no efficacy in the treatment of BPD |
| May, 2002 | Gabapentin is FDA-approved for treatment of postherpetic neuralgia in adults. |
| May, 2004 | Pfizer agrees to a $430 million settlement for Warner-Lambert’s promotion of gabapentin for uses not approved by the FDA |
| July 1, 2004 | Florida Medicaid institutes a prior authorization program restricting gabapentin use to FDA approved indications |