Depomed Says It Was Cheated Out Of Orphan Drug Exclusivity

Law360, Washington (August 23, 2013, 5:50 PM ET) -- Depomed Inc. urged a Washington federal judge Friday to force the U.S. Food and Drug Administration to give the company seven years of drug exclusivity for its pain drug Gralise, claiming the agency went beyond its authority and added new limitations to its orphan drug program.

According to the drugmaker, the FDA inappropriately determined that Depomed had to show Gralise was clinically superior to other drugs already approved to treat post-herpetic neuralgia, pain stemming from a rash associated with shingles. However, Depomed maintained Congress never gave...
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Case Information

Case Title

DEPOMED INC. v. U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES et al


Case Number

1:12-cv-01592

Court

District Of Columbia

Nature of Suit

Other Statutory Actions

Judge

Ketanji Brown Jackson

Date Filed

September 25, 2012

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