ISTA Pharmaceuticals pleads in federal case

ISTA Pharmaceuticals pleads guilty to promoting drug for unapproved use; Will pay $33.5M

Associated Press

BUFFALO, N.Y. (AP) -- Drug-maker ISTA Pharmaceuticals has pleaded guilty in a federal case involving its eye drug Xibrom.

The Justice Department says the case was settled in U.S. District Court in Buffalo Friday. ISTA, which was acquired by Rochester-based Bausch & Lomb last year, admits to promoting Xibrom for uses beyond what the Food and Drug Administration approved.

It also pleaded guilty to violating anti-kickback statutes by sponsoring various events in hopes of persuading doctors to prescribe Xibrom.

The company has agreed to pay $33.5 million in fines and fees.

Bausch & Lomb says the conduct took place from 2006 to 2011, well before it took over ISTA, and that it's cooperated in the investigation.

Xibrom is an anti-inflammatory approved by the FDA to treat pain and inflammation after cataract surgery.

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