GlaxoSmithKline Plc lost a U.S. Supreme Court appeal aimed at stopping a generic version of its Paxil antidepressant, a drug that once generated $3 billion a year in sales for the British drugmaker.
The justices, without comment, today left intact a lower court ruling that invalidated part of a Glaxo patent that once shielded Paxil from […]
In February 2006, the CAFC affirmed a lower court’s invalidation of Apotex’s Paxil patent — finding that its product-by-process claims were invalid because they attempted to recapture the end-product from the public domain. According to that decision, “once a product is fully disclosed in the art, future claims to that same product are precluded, even […]
Over the past six years, ten FDA approved drugs have been withdrawn from the market due to deaths and injuries, leading lawmakers to accuse the FDA of not doing its job in protecting the public from unsafe drugs and to call for measures of improvement.
On June 20, 2006, the New York Times reported that “two […]
The US Supreme Court has ruled against an appeal by UK drug major GlaxoSmithKline calling for patent protection on its antidepressant Paxil/Seroxat (paroxetine), reports the Associated Press.
GSK brought the motion to stop copy-cat versions of its drug being made by privately-held Canadian generics firm Apotex. The long-standing dispute between the two companies has run up […]
Almost everyone else had been granted their freedom for the day when Ricky Williams began his slow march across the field, like a prisoner being led into court with shackles. His feet were, like the rest of him, already an hour behind schedule, but that didn’t seem to offer any lift as they scuffed across […]
WASHINGTON (Reuters) - Young adults who took GlaxoSmithKline Plc’s (GSK.L: Quote, Profile, Research) (GSK.N: Quote, Profile, Research) antidepressant Paxil in clinical trials were more likely to report suicidal behaviour than others who got a placebo, the company and U.S. regulators said on Friday.
Glaxo said it voluntarily added the findings to the prescribing instructions on Paxil’s […]
WASHINGTON, DC, United States (UPI) — The manufacturer of Paxil has notified doctors that the anti-depressant may increase the likelihood that young adults might attempt suicide.
GlaxoSmithKline said the information, which will be included on Paxil`s warning label, is based on a clinical trial involving 15,000 patients, The New York Times reported. While there were few […]
WASHINGTON (AP) — The antidepressant Paxil may raise the risk of suicidal behavior in young adults, GlaxoSmithKline and the Food and Drug Administration warned Friday in a letter to doctors.
The warning letter was accompanied by changes to the labeling of both Paxil and Paxil CR, a controlled-release version of the drug, also called paroxetine.
A recent […]
FDA Warns that Paxil Makes Depressed Adults Suicidal
By Peter R. Breggin, M.D.
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Getting the FDA to move forward by presenting it with scientific data is like using a peacock feather to tickle a sleeping giant tortoise on its shell. Many people die before the agency opens its eyes and then it barely reacts at all.
Bloated […]
Thursday June 1, 5:20 am ET
BOSTON, June 1 /PRNewswire/ — New research is shedding light on the ongoing controversy over whether antidepressant medications help depressed children and adolescents — and how the benefits compare to the risk of suicidal impulses and attempts, reports the June issue of the Harvard Mental Health Letter.
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Researchers examined data […]