Lilly resolves FDA manufacturing dispute
pharmafile | November 5, 2003 | News story | Manufacturing and Production |
Two Eli Lilly manufacturing sites have passed FDA inspections resolving a long-running dispute and paving the way for the launch of two new drugs.
Resolution of the manufacturing issues will represent final FDA approval for Cymbalta, Lilly's new treatment for depression and a successor to Prozac, as well as an injectable form of Zyprexa for schizophrenia.
Lilly expects Cymbalta to be launched next summer, following final negotiations for its product label and a pre-approval site inspection of its dry products facility.
The approval of Zyprexa IntraMuscular, has been held up since March 2001, but is now only awaiting a final site inspection.
A routine FDA inspection of the company's Indianapolis injectable and dry products manufacturing facilities in 2001 found the company to have fallen below acceptable levels of manufacturing standards (GMP), delaying the final approval of products to have been manufactured there.
Lilly chief executive Sidney Taurel said: "The FDA assessment recognises the significant progress we have made in implementing our GMP improvement plan. This is a result of our focus on improving manufacturing quality, which includes the substantial investments we have made since 2001."
Mr Taurel admitted that there was nevertheless considerable work needed to improve the company's manufacturing facilities.
"Although the FDA assessment is an important milestone, we still have considerable work to do to reach our ultimate goal of building and sustaining world-class manufacturing and quality capabilities. We are committed to these efforts with a renewed sense of urgency and enthusiasm."
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