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  • Not enacted
    The President has not signed this bill
  • The senate has not voted
  • The house has not voted
      house Committees
      House Committee on Energy and Commerce
      Health
    IntroducedOctober 8th, 2009

Bill Details

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Title

Drug Price Competition Act of 2009

Official Title

To amend the Federal Food, Drug, and Cosmetic Act to define the term "first applicant" for purposes of filing an abbreviated application for a new drug.

Summary

Drug Price Competition Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant to submit a substantially complete application that contains and lawfully maintains a certification for such drug.

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