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Many believe a majority of the proposed labeling changes will be implemented based on insignificant information obtained from spontaneous adverse event reports. In addition, the temporary differences between generic and corresponding branddrug labeling may cause confusion as well as doubt in the therapeutic equivalence of generic drugs to their corresponding brandname product. The current proposal does not set a time limit for FDA review and response to CBE0 supplements, which could lead to extended periods of discrepancy between brand and generic labeling. There is also concern that multiple CBE0 supplements addressing the same safety issue will be submitted.
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On the other hand, antispasmodics have very few side effects so doctors are happy to prescribe them.
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