(Reuters) – Catalyst Pharmaceuticals Inc said on Wednesday it has filed a lawsuit against the U.S. Food and Drug Administration, challenging the recent approval of Jacobus Pharmaceutical Co’s drug, Ruzurgi, for a rare neuromuscular disease.
Shares of Catalyst fell nearly 1.3% in early trading and has lost about 40% of its value since Ruzurgi was approved in May.
However, Firdapse’s $375,000 a year price tag has drawn criticism, including from presidential candidate and U.S. senator Bernie Sanders.
“The FDA has misapplied its regulations, contradicting decades of precedent and has undercut Catalyst’s orphan drug exclusivity,” the company, which filed the lawsuit in the United States District Court for the Southern District of Florida, said in a statement.
An FDA spokeswoman declined to comment.
Reporting by Saumya Sibi Joseph in Bengaluru and Michael Erman in New York; Editing by Arun Koyyur