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Lilly Gains New Indication for Forteo, but Also a REMS and Patient Registry
Lilly Gains New Indication for Forteo, but Also a REMS and Patient Registry
B Sandburg
20090724
2009 Aug 24
The Pink Sheet Daily
Lilly Gains New Indication for Forteo, but Also a REMS and Patient Registry
The Pink Sheet Daily. 2009 Aug 24, B Sandburg
Lilly is setting up a voluntary Forteo patient registry to collect data on potential bone cancer risk as part of FDA's approval of a new indication for the osteoporosis treatment. The company is also instituting a Risk Evaluation and Mitigation Strategy to control for the risk. On July 22, FDA expanded use of the injectable drug to include treatment of glucocorticoid-induced osteoporosis (GIO) in adult patients at high risk for fracture. The labeling for Forteo (teriparatide) has included a boxed...