Lilly Forteo
Executive Summary
Company is expecting an FDA-483 inspection report at the end of March following an ongoing pre-approval inspection of Building 358 in Indianapolis. Because the inspection closely follows a warning letter related to a pre-approval inspection for Zyprexa IM, global process changes have yet to be implemented, Lilly said (1"The Pink Sheet" March 12, p. 26). The firm continues to expect a launch for the osteoporosis drug Forteo (teriparatide) during the fourth quarter. A recent inspection of a Lilly plant in Puerto Rico resulted in few observations and no 483, the company added
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