SuperGen Accused of Misleading Claims
The Food and Drug Administration accused SuperGen Inc. of making misleading claims about a cancer therapy, in the agency’s first news release in 17 years warning about a medicine’s promotion.
The news sent the Dublin, Calif., company’s shares tumbling 54 cents, or 17%, to $2.55 on Nasdaq.
The FDA said a Nov. 15 SuperGen release announcing FDA approval of Mitozytrex to treat stomach and pancreatic cancer exaggerated the drug’s benefits and failed to explain its risks.
The FDA generally issues warning letters directly to companies when it finds violations of marketing rules. However, the agency said SuperGen’s release was “particularly egregious” and merited a public clarification.
From Bloomberg News
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