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Category: Defective Drugs

Living Off the Label

03/24/2014
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Doctors and physicians are given a great deal of discretion when it comes to prescribing drugs for uses other than those indicated by the FDA. This is known as “off-label” use. The FDA, realizing the danger of off-label promotion in its 2009 guidance, has set forth rules to restrict the […]

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Drug Supplement Endangers Kids

03/19/2014
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It is a supplement used to treat children with a genetic disorder but instead has hospitalized at least one child. The Food and Drug Administration (FDA) reports lots of L-citrulline, sold by Medisca, had none of the active drug. The Plattsburgh, N.Y.-based compounding company was forced to recall eight lots […]

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Compounding Problems

03/18/2014
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In the production of pharmaceutical drugs there are large scale drug manufacturers which produce brand name and generic drugs, and there are compound pharmacies which are specialty pharmacies made to fill out unique orders for clients using already existing medications. Drug manufacturers fall under FDA standards and regulations, while compounding […]

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Proposed FDA Label Changes Irking Generic Drugmakers

03/10/2014
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Generic drugmakers are increasingly becoming more frightened of the threat of products liability lawsuits because of a proposed rule that would require them to change their labels if the company receives new safety information about the drug. These label changes would overturn a three decade old regime of prohibiting generic […]

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Generic Drug Preemption

03/10/2014
Defective Drugs
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In 2009, the U.S. Supreme Court in Wyeth v. Levine held that brand-name drug manufacturers are responsible for their warning labels and may be liable for not adding additional warnings when new risks are discovered. However, in 2011, the Supreme Court held that failure-to-warn claims brought against generic drug makers […]

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New Opioid Pain Pill to Hit the Market

03/3/2014
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Do we really need a new highly addictive opioid analgesic on the market to treat chronic pain, especially considering the high rates of drug addiction in the U.S? The drug Zohydro is set to be marketed come March and its approval is sparking a firestorm from consumer, drug addiction and […]

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