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FDAnews Drug Daily Bulletin
Sept. 28, 2012 | Vol. 9 No. 191
Depomed Sues FDA, Alleges Agency Wrongfully Denied Orphan Drug Exclusivity
Depomed is taking the FDA to court, claiming the agency violated federal laws and its own regulations when it denied the company’s orphan drug Gralise seven years of marketing exclusivity. The FDA unfairly required “additional hurdles” for Gralise’s (gabapentin) orphan exclusivity — barriers that are not in the Orphan Drug Act or FDA regulations, Depomed alleges in its complaint, filed Tuesday in the U.S. District Court for the District of Columbia.
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