The U.S. Justice Department has asked Cephalon Inc. (CEPH) about
documents relating to alleged off-label promotion of its Treanda
treatment for chronic lymphocytic leukemia, the pharmaceutical
industry news site Pharmalot.com reported Monday.
The June request to the Pennsylvania-based drug maker concerned
first-line treatment of non-Hodgkin's lymphoma, for which Treanda
isn't approved, according to sources familiar with the request.
Also requested were clinical studies that could be used to support
off-label use before the studies were completed or submitted for
review by the U.S. Food and Drug Administration.
A Cephalon spokeswoman declined to comment, Pharmalot.com
reported.
Israeli drug maker Teva Pharmaceutical Industries Ltd. (TEVA,
TEVA.TV) is attempting to complete a $6.2 billion acquisition of
Cephalon, and has said it expects the deal to be completed during
the third quarter, pending approval by U.S. and European regulators
as well as Cephalon shareholders.
Full story at
http://www.pharmalot.com/2011/07/feds-probe-cephalon-for-off-label-treanda-promotion/
-Dow Jones Newswires; 212-416-2900