Category: Generic Drug Safety
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July 2013 Update: New FDA Action To Be Taken In Or About September On Issue Of Drug Label Revisions By Generic Manufacturers
Allowing Supplemental Applications For Proposed Labeling Changes Might End Federal Preemption Shield From Legal Liability That Came With Mensing Ruling (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: The FDA’s long-awaited proposed rule on…
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Despite FDA Regulations, Generic Drug Labels Often Failed To Match Brand Name Drug Safety Warnings
Two-Thirds Of The Generics Did Not Have Identical Labeling, And Up To 9% Showed Differences Of More Than 10 Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) A disturbing new study about drug labeling for generic medications…
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Generic Drugs Post-Mensing Ruling: One Proposed Solution To The Legal Compensation And FDA Drug Safety Problems Supreme Court Created
At Least, This November 2012 Article In The New England Journal Of Medicine Makes The Point That Something Needs To Be Done Soon, Rather Than Later (Posted by Tom Lamb at DrugInjuryWatch.com) The June 2011…
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March 2012 Update: Generic Drug Manufacturers Immunity By Means Of Mensing Preemption Ruling
One Year After The Hearing In Pliva v. Mensing, Some Momentum Builds For (Once Again) Allowing Drug Injury Lawsuits On All Prescription Medications, Generic As Well As Brand Name (Posted by Tom Lamb at…
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Public Citizen Group Files FDA Petition To Fix Problems Exposed By Mensing Case Ruling
Generic Drug Companies Should Have To Update Side Effect Warnings Or Face Drug Injury Lawsuits (Posted by Tom Lamb at DrugInjuryWatch.com) On August 29, 2011 the consumer advocacy group Public Citizen took action in…
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Generic Drug Company Should Not Be Allowed To Use Federal Preemption To Defeat Lawsuits
U. S. Supreme Court Will Hear Oral Arguments On This Legal Issue In Drug Injury Lawsuit Involving Gladys Mensing (Posted by Tom Lamb at DrugInjuryWatch.com) _____________________________________________________________________ UPDATE: The Pliva, Inc., et al. v. Mensing case was…
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Generic Drug Manufacturer ETHEX Corp. Is Being Shut Down By KV Pharmaceuticals
Troubled Company Pleads Guilty To Criminal Charges, Pays $27.6 Million In Fines And Restitution For Its Conduct Related To Quality-Control Issues (Posted by Tom Lamb at DrugInjuryWatch.com) We last wrote about the troubled generic…
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Generic Drug Maker Caraco Fails To Correct Manufacturing Problems First Discovered In May 2008
FDA And U.S. Marshals Seize Drug Products From Caraco’s Three Michigan Facilities Due To Continuing Lack Of Quality Controls (Posted by Tom Lamb at DrugInjuryWatch.com) On June 25, 2009 the FDA issued a press…
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May 2009 Digoxin Recall By AS Medication Solutions Seems To Be About Six-Weeks Late
This Company Repackaged Caraco Digoxin Tablets That Were Recalled March 31, 2009; Why Did They Delay Their Recall Notice? (Posted by Tom Lamb at DrugInjuryWatch.com) On May 11, 2009 AS Medication Solutions, LLC —…