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The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States.
Drug Class and Time Length Of Drug Withdrawal Cymbalta MechanismCymbalta is a serotonin and norepinephrine reuptake inhibitor (SNRI). It works by restoring the balance of certain natural substances in the brain (serotonin and norepinephrine), which helps to improve certain mood problems.
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May diminish public expectation that drugs will be evaluated for safety and efficacy before use.
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The FDA is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury, and the issue has been discussed at the FDA
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