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The FDA recently approved two new generic versions of Boehringer Ingelheim Pharmaceuticals Inc.'s popular anti-arthritis medication, Mobic. This medication, which treats the symptoms of both osteo- and rheumatoid arthritis, had sales of over a billion dollars in the United States during the last fiscal year. The two generic alternatives, known by the generic name Meloxicam, are produced by the Israeli company Teva Pharmaceutical Industries Ltd and Par Pharmaceuticals Co, Inc, and are available in doses of 7.5 and 15 mg. Find out more about Meloxicam here.
I had always been told that the active ingredients in generic medications had to be exactly the same as their brand name counterparts; that the only differences allowed were in the inactive ingredients, such as binders. But as I began to hear from more and more people who insisted that the generic of a particular medication was not as effective for them as the brand name, I decided it was time to dig deeper. As it turns out, brand name and generic medications aren't necessarily exactly the same. The differences and the reason we're often told they are equilivant are tied up in the definitions of three terms – bioequivalence, therapeutic equivalence and bioavailability. Bioequivalence means that two drugs given to the same patient in the same dosage regimen will result in equivalent concentrations of the drug in plasma and tissues. Generic drugs are required to be bioequivalent to the original brand name drug. Therapeutic equivalence means that...
A five-member majority of the U. S. Supreme Court concluded in late June that "it makes little sense" to bar suits against generic drug-makers while allowing them against brand-name manufacturers1.
The majority, however, sided with the supremacy of federal law in its potential conflict with state law, in that federal law bars manufacturers from labeling that varies from the FDA-approved labeling of the branded drugs they imitate. Thomas reasoned in writing the majority opinion that it would be "rare" that harmful side effects could become known by the time generic drugs come on the market.
Such thinking flies in the face of the importance of post-market surveillance and the continued collection and analysis of data upon a drug's usage - even after it is manufactured in generic camps. This is because the initial approvals and labeling for branded drugs are largely based on clinical trials in which research participants are highly screened. The results are recognized not to be wi...
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