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Generic drugs poster

The Drug Price Competition and Patent Term Restoration Act of 1984 gave FDA the authority to accept abbreviated new drug applications (ANDAs) for generic versions of post-1962 drugs. The first approved ANDA was for generic disopyramide, marketed as Norpace and used in the treatment of cardiac arrhythmias. As a result of this legislation, several Divisions in the Office of Drug Standards added branches to assist with the review of ANDAs. The law also provided manufacturers with the opportunity to apply for an extra five years of patent protection to make up for time lost during the FDA approval process.
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