Increase Integrity of Single-use Assemblies Immediately Before Use.
ATMI Life Science
Eli Lilly looks to have finally overcome the non-compliance issues at its sites in Indianapolis, evading a fine and raising the prospects for the launch of two of its most important pipeline drugs.
The company first fell foul of a US Food and Drug Administration (FDA) inspection in March 2001, when it received a warning letter after failing a routine inspection associated with the approval of the firm's rapidly-acting intramuscular formulation of Zyprexa (olanzapine), the firm's top-selling antipsychotic medications. The agency cited failure in quality control and other validation processes.
Since then, there has been a running dialogue between the company and the agency about the state of compliance at the facilities, but the FDA's decision that the plants are now ready for re-inspection represents the first real advance for Lilly.
No date has been set for the review but, if all goes to plan, the new formulation of Zyprexa and Cymbalta (duloxetine), a follow-up to the firm's former top-selling antidepressant Prozac (fluoxetine) could finally reach the market. Lilly has suggested Cymbalta could be launched next summer.
Since March 2001, Lilly has hired 750 experienced people to work permanently in its Indianapolis manufacturing and quality operations and redeployed several hundred employees on a short- or long-term basis.
Lilly also recently said it will spend $200 million (€172m) more annually to comply with new levels of manufacturing standards and fund the growth of its manufacturing operations.
