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ANDA patent certifications must be updated to include GATT patent date, Glaxo and Bristol assert.

Executive Summary

ANDA PATENT CERTIFICATION MUST BE UPDATED TO INCLUDE GATT INFORMATION, GLAXO and Bristol-Myers Squibb contend in April 13 and April 14 letters to FDA. Both companies note that FDA's implementing regulations for the Waxman/Hatch Act state that "an applicant shall amend a submitted certification if, at any time before the effective date of the approval of the application, the applicant learns that the submitted certification is no longer accurate."
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PS026114

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