Society and culture Gabapentin

1 society , culture

1.1 sales
1.2 fda approval
1.3 off-label promotion

1.3.1 franklin v. pfizer case


1.4 brand names
1.5 related drugs

society , culture
sales

gabapentin best known under brand name neurontin manufactured pfizer subsidiary parke-davis. pfizer subsidiary named greenstone markets generic gabapentin.

in december 2004 fda granted final approval generic equivalent neurontin made israeli firm teva.

neurontin began 1 of pfizer s best selling drugs; however, pfizer criticized , under litigation marketing of drug. faced allegations parke-davis marketed drug @ least dozen supposed uses fda had not approved. has been used mainstay drug migraines, though not approved such use in 2004.

fda approval

gabapentin approved u.s. food , drug administration (fda) in december 1993, use adjuvant (effective when added other antiseizure drugs) medication control partial seizures in adults; indication extended children in 2000. in 2004, use treating postherpetic neuralgia (neuropathic pain following shingles) approved.

off-label promotion

although small, non-controlled studies in 1990s—mostly sponsored gabapentin s manufacturer—suggested treatment bipolar disorder gabapentin may promising, preponderance of evidence suggests not effective. subsequent corporate acquisition of original patent holder, pharmaceutical company pfizer admitted there had been violations of fda guidelines regarding promotion of unproven off-label uses gabapentin in franklin v. pfizer case.

reuters reported on 25 march 2010, pfizer inc violated federal racketeering law improperly promoting epilepsy drug neurontin ... under federal rico law penalty automatically tripled, finding cost pfizer $141 million. case stems claim kaiser foundation health plan inc. misled believing neurontin effective off-label treatment of migraines, bipolar disorder , other conditions. pfizer argued kaiser physicians still recommend drug uses.

bloomberg news reported during trial, pfizer argued kaiser doctors continued prescribe drug after health insurer sued pfizer in 2005. insurer s website still lists neurontin drug neuropathic pain, pfizer lawyers said in closing argument.

the wall street journal noted pfizer spokesman christopher loder said, disappointed verdict , pursue post-trial motions , appeal. later add verdict , judge s rulings not consistent facts , law.

franklin v. pfizer case

according san francisco chronicle, off-label prescriptions accounted 90 percent of neurontin sales.

while off-label prescriptions common number of drugs , legal, marketing of off-label uses of drug not. in 2004, warner-lambert (which subsequently acquired pfizer) agreed plead guilty activities of parke-davis subsidiary, , pay $430 million in fines settle civil , criminal charges regarding marketing of neurontin off-label purposes. 2004 settlement 1 of largest in u.s. history, , first off-label promotion case brought under false claims act.

brand names

gabapentin marketed under brand name neurontin , since became generic, has been marketed under many other brand names. extended-release formulation of gabapentin once-daily administration introduced in 2011 postherpetic neuralgia under brand name gralise.

a capsule of gabapentin.


related drugs

parke-davis developed drug called pregabalin successor gabapentin. pregabalin brought market pfizer lyrica after company acquired warner-lambert. pregabalin related in structure gabapentin. new drug atagabalin has been trialed pfizer treatment insomnia.

a prodrug form (gabapentin enacarbil) approved in 2011 under brand name horizant treatment of moderate-to-severe restless legs syndrome , in 2012 postherpetic neuralgia in adults. designed increased oral bioavailability on gabapentin.