Sebela Pharmaceuticals Inc. has accused Nivagen Pharmaceuticals Inc. of falsely advertising an unapproved skin cream as a generic substitute for Sebela’s topical corticosteroid Pramosone.
Nivagen has listed its unauthorized product as bioequivalent to Pramosone in several key databases that doctors and pharmacists consult when deciding whether to use a generic rather than a brand-name drug, according to a lawsuit filed May 8 in Delaware federal court. The company allegedly says the same thing to doctors, hospitals, pharmacies, pharmacists, and drug wholesalers.
But the Food and Drug Administration hasn’t approved Nivagen’s product as a generic substitute for Pramosone, and the company ...
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