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You are here: Home / NEWS . . . . . . . . / Government Agencies / North American / The United States / FDA / Generic drugs approved by different FDA process

Generic drugs approved by different FDA process

July 26, 2011 By Norma Leave a Comment

By Linda A. Johnson, AP Business Writer

WASHINGTON — Generic drugs go through what the Food and Drug Administration calls an abbreviated approval process.

But it takes three times as long as FDA reviews of new experimental drugs because of the sheer volume of applications, many of which are submitted years before the original drug’s patent will expire.

Because so many widely used drugs are approaching the end of their patents, there are now more than 2,400 generic drug applications awaiting FDA approval.

Generic drugs are comparable to brand-name “innovator” drugs in performance, intended use, strength, dosage form, route of administration and quality. Because of that, their effectiveness and safety aren’t tested in animals and people.

Instead, the manufacturer must prove scientifically that a generic drug performs the same as the original one in people, meaning the same amount of active ingredients enters the bloodstream in the same amount of time. Often, that’s done by giving a few dozen healthy volunteers the generic drug, then taking repeated blood samples to test the level of the drug over time.

Read the entire article here.

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Filed Under: FDA, United States Tagged With: FDA, generic drug approval process

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