FROM OUR EXPERTS
I’m sure most of you with COPD (Chronic Obstructive Pulmonary Disease) have heard of Spiriva , and I am quite sure, as well, that many of you are taking it. Since it is still a relatively new medicine, I wrote this article to answer questions, clear up any confusion, and help you get on with your life by achieving the most effective COPD management possible. First a little background. I’d been hearing about Spiriva for a while before it became available in the United States. I heard that it worked like Atrovent , a staple of COPD treatment (most of my patients were on Combivent, a combination of Atrovent and Albuterol) and that Spiriva was supposed to be sort of a “super Atrovent.” A more powerful medication in a once-a-day dose! At the time, a patient of mine was able to obtain Spiriva from Germany, so it was nice to have a preview by hearing how it worked for him – and he said that he was breathing a lot better. I was excited at the prospect of it be...
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.
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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