Mylan has an exclusive license to an Orange Book patent pertaining to Paxil
CR which expires in July 2016, with pediatric exclusivity extending until Jan.
The government also alleges that the company prepared and published a misleading medical journal article providing false information about the efficacy of Paxil
in patients under age 18.
Prosecutors claimed GSK encouraged use of Paxil
for children although it was not approved for use by anyone under the age of 18.
It said it had settled "the vast majority of product liability cases" relating to Paxil
and "the substantial majority" of those relating to Avandia.
Depressed patients taking Paxil
showed much greater change in these traits, as assessed by personality tests, than patients given placebo pills.
A dermatologist who was treating Jake for acne prescribed Paxil
off-label for treatment of his body dysmorphic disorder, a psychiatric condition in which a person is excessively concerned about a real or imagined defect in his or her physical appearance.
has a short "half-life"--the time after taking a drug at which half of the dose remains in the body--and therefore a short wash-out period when compared to Prozac.
Due to the lack of adequate and well-controlled studies in humans, Paxil
maintains its Pregnancy Category C status, according to GSK.
Glaxo was allowed to reintroduce Paxil
CR and another drug - its Avandamet diabetes treatment - after it identified the source of manufacturing problems and took corrective action.
Shares in GlaxoSmithKline closed 9p higher at 1336p after SkyPharma welcomed this week's announcement Paxil
, GSK's anti-depressant, would be made available at pharmacies throughout the US.
The company's stock fell sharply in March when the Food and Drug Administration (FDA) forced it to withdraw antidepressant Paxil
CR and its Avandamet diabetes treatment amid concerns they were of poor quality.
Glaxo said sales of medicines over the 12 months to December 31 were one per cent higher than a year ago, despite sharp falls in demand for antidepressants Paxil
Glaxo said sales of medicines over the 12 months to December 31 were 1% higher than a year ago, despite sharp falls in demand for anti-depressants Paxil
Choose one: Prozac, Paxil
, Celexa, Zoloft, Wellbutrin, Effexor, Remeron, Serzone, Luvox, Lexapro.
Seroxat - known as Paxil
in the US - has not been cleared by the authorities there for use on children with depression.