FDA Says Nyet to Abbott’s Controlled-Release Hydrocodone

The FDA refused to approve an extended-release form of the painkiller Vicodin last week.

The FDA refused to approve an extended-release form of the painkiller Vicodin last week.

Abbott has been trying to slide a new “controlled-release” formulation of its hydrocodone-with-acetaminophen cocktail, popularly known as Vicodin, through the FDA approval process; and last week the company confirmed receiving a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA).

As potentially the first extended release medication in the class, Abbott’s primary reason for the move is obvious… to reap huge profits on a new formulation, enjoying that sweet honeymoon-period before the generics hit the market.

The currently available short-acting hydrocodone and acetaminophen combo (HC/APAP – brand name Vicodin) has been available in generic form from several pharmaceutical companies for years, leaving the margin for profits painfully slim.

So far, the FDA isn’t biting.

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Image courtesy Wikipedia the free encyclopedia.

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One Response to “FDA Says Nyet to Abbott’s Controlled-Release Hydrocodone”

  1. Greg House Says:

    bbott’s really looking to generate more income to their accounts, trying to create some new medication, the FDA wait until now controlled as these maneuvers vicodin … because I seek to use my pain from cancer and always read the information findrxonline.com being reliable.

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