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    Innovator Drug

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    kooldude2437
    An Abbreviated New Drug Application (ANDA) allows generic drug manufacturers to file for approval of a generic version of an existing approved drug. The ANDA contains data to demonstrate the generic drug is bioequivalent to the original, showing it delivers the same amount of active ingredients in the same time period. This allows generic drugs to be approved without conducting new clinical trials, expediting availability of lower cost alternatives. The Hatch-Waxman Act of 1984 established bioequivalence as the standard for approving generic copies and balancing generic availability with patent protection for brand drugs.

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    Innovator Drug

    Uploaded by

    kooldude2437
    34 views1 page
    An Abbreviated New Drug Application (ANDA) allows generic drug manufacturers to file for approval of a generic version of an existing approved drug. The ANDA contains data to demonstrate the generic drug is bioequivalent to the original, showing it delivers the same amount of active ingredients in the same time period. This allows generic drugs to be approved without conducting new clinical trials, expediting availability of lower cost alternatives. The Hatch-Waxman Act of 1984 established bioequivalence as the standard for approving generic copies and balancing generic availability with patent protection for brand drugs.

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    An Abbreviated New Drug Application (ANDA) allows generic drug manufacturers to file for approval of a generic version of an existing approved drug. The ANDA contains data to demonstrate the generic drug is bioequivalent to the original, showing it delivers the same amount of active ingredients in the same time period. This allows generic drugs to be approved without conducting new clinical trials, expediting availability of lower cost alternatives. The Hatch-Waxman Act of 1984 established bioequivalence as the standard for approving generic copies and balancing generic availability with patent protection for brand drugs.

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    34 views1 page

    Innovator Drug

    Uploaded by

    kooldude2437
    An Abbreviated New Drug Application (ANDA) allows generic drug manufacturers to file for approval of a generic version of an existing approved drug. The ANDA contains data to demonstrate the generic drug is bioequivalent to the original, showing it delivers the same amount of active ingredients in the same time period. This allows generic drugs to be approved without conducting new clinical trials, expediting availability of lower cost alternatives. The Hatch-Waxman Act of 1984 established bioequivalence as the standard for approving generic copies and balancing generic availability with patent protection for brand drugs.

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    An 

    Abbreviated New Drug Application (ANDA) is an application for a U.S. generic


    drug approval for an existing licensed medication orapproved drug.

    The ANDA contains data which when submitted to FDA's Center for Drug Evaluation
    and Research, Office of Generic Drugs, provides for the review and ultimate approval of
    a generic drug product. Once approved, an applicant may manufacture and market the
    generic drug product to provide a safe, effective, low cost alternative to the American
    public. ANDAs have grown by 70% since November 2008.[1] The Section IV challenge
    has been credited with suppressing new drug innovation.[2]

    A generic drug product is one that is comparable to an innovator drug product in dosage


    form, strength, route of administration, quality, performance characteristics and intended
    use. All approved products, both innovator and generic, are listed in FDA's Approved
    Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

    Generic drug applications are termed "abbreviated" because they are generally not
    required to include preclinical (animal) and clinical (human) data to establish safety and
    effectiveness. Instead, generic applicants must scientifically demonstrate that their
    product is bioequivalent (i.e., performs in the same manner as the innovator drug). One
    way scientists demonstrate bioequivalence is to measure the time it takes the generic drug
    to reach the bloodstream in 24 to 36 healthy volunteers. This gives them the rate of
    absorption, or bioavailability, of the generic drug, which they can then compare to that of
    the innovator drug. The generic version must deliver the same amount of active
    ingredients into a patient's bloodstream in the same amount of time as the innovator drug.

    Using bioequivalence as the basis for approving generic copies of drug products was
    established by the Drug Price Competition and Patent Term Restoration Act of 1984, also
    known as the Hatch-Waxman Act. This Act expedites the availability of less costly
    generic drugs by permitting FDA to approve applications to market generic versions
    of brand-name drugs without conducting costly and duplicative clinical trials. At the
    same time, the brand-name companies can apply for up to five additional years longer
    patent protection for the new medicines they developed to make up for time lost while
    their products were going through FDA's approval process. Brand-name drugs are subject
    to the same bioequivalence tests as generics upon reformulation.

    Ref ; wikipedia

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