Drug Manufacturer Watson Sues FDA Over Generic Actos Release

Watson Pharmaceuticals has filed a lawsuit against the FDA for denying shared exclusivity, despite the fact that the drug company followed all the FDA’s requirements. Watson planned to release the generic version of Takeda Pharmaceutical’s controversial Actos drug on August 17th. In 2010, Watson got approval to market the generic pioglitazone … [Read more...]

Sun Pharmaceuticals Issues Warfarin Drug Recall

Indian Company Under Fire Again for Warfarin Drug Recall Sun Pharmaceuticals has been closely scrutinized by the Food and Drug Administration recently for problems with generic drugs leading to drug recalls in the US. The company, along with other generic drug manufacturers in India, met with FDA head Margaret A. Hamburg in February of this year … [Read more...]

FDA Chief to Visit India Amid Generic Drug Concerns

Head of FDA Plans Visit to India as Concerns Grow Regarding Generic Drugs Manufactured There Amid rising concerns about the quality of generic drugs manufactured in India, FDA head Margaret A. Hamburg announced that she would head to the country to investigate some troubled manufacturers. Several generic drug manufactures in India have come under … [Read more...]

US Supreme Court Reviews Personal Injury Lawsuits Against Generic Drugs

Generic Drugs Previously Exempt from Personal Injury Lawsuits In 2011, the Supreme Court ruled 5 – 4 that patients cannot levy personal injury lawsuits against manufacturers of generic drugs if they fail to warn about side effects. The ruling was based on the FDA’s regulation that generic drugs must be functionally, chemically equivalent to their … [Read more...]

Pfizer Held Liable for Generic Drug Injuries

Alabama Court Holds Brand-Name Pfizer Liable for Injuries from Generic Drug Counterparts In Alabama, a state Supreme Court justice ruled that brand-name drug makers like Pfizer can and should be held responsible for personal injury caused by generic drugs, despite the fact that generic drugs are made by different pharmaceutical companies. The … [Read more...]

FDA May Allow Generic Drugs to Update Label Information

FDA Proposes Rule for Generic Drug Manufacturers to Update Safety Info on Label On Friday, November 8th, the Food and Drug Administration proposed a rule that would allow generic drug manufacturers to update the labels on their products if a potential safety problem, with the generic or brand name drug, is discovered. In June of this year, the … [Read more...]

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