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Court rejects Celexa patent listing

Executive Summary

FDA's "ministerial" role in declining to list certain patents in the "Orange Book" affirmed by a D.C. federal judge Aug. 13. Court rules FDA did not err in refusing Alphapharm's request to list a patent for Forest's antidepressant Celexa and accept its ANDA with a Paragraph IV certification. No patents for Celexa are listed; consequently, no ANDA filers will receive 180-day exclusivity for generic citalopram...





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