FDA Wrongly Denied Orphan Drug Exclusivity, Depomed Claims

Law360, New York (September 26, 2012, 12:49 PM EDT) -- Depomed Inc. on Tuesday sued the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services, alleging they wrongly denied the company market exclusivity for Gralise despite granting the shingles-related pain remedy orphan drug status for treating a rare condition.

According to Depomed’s complaint, filed in Washington, the FDA had granted the Menlo Park, Calif.-based drugmaker orphan drug status for the use of Gralise to treat postherpetic neuralgia — post-disease pain related to shingles, a virus in the herpes family which causes...
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