RESEARCH-MATERIALS.COM

Updated 369 days ago
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The policy will affect the way salt is expressed in the non-proprietary name, or non-brand name, of a new drug as of May 1, 2013... If we applied the policy today using a current drug as an example, this is how the policy would impact the name. If Morphine Sulfate ER tablets were released after May 1, 2013, it would not have the salt, in this case the sulfate, in its name, and its specific salt form and strength would be noted elsewhere on its label. For this example, the name would become Morphine ER tablets. This new policy will be applied to new drugs as of May 1, 2013 and may possibly affect a few existing drugs... An active moiety is the molecule or ion, excluding those appended portions of the molecule that cause the drug to be a salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule. The active moiety is responsible for the physiological or pharmacological action of the drug..
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