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Posted by Griobhtha on November 16, 2003, at 11:35:06
October 30, 2003 08:03
FDA Informs Lilly of Its Overall Manufacturing Assessment
Jump to first matched termINDIANAPOLIS, Oct 30, 2003 (BUSINESS WIRE) -- The U.S. Food and Drug Administration (FDA) has informed Eli Lilly and Company (NYSE:LLY) that the agency now considers the company's injectable and dry products facilities in Indianapolis to have reached a level of current Good Manufacturing Practices (GMP) compliance that will allow preapproval site inspections to occur for Cymbalta(TM) and Zyprexa(R) IntraMuscular, as the agency deems necessary.
"The FDA assessment recognizes the significant progress we have made in implementing our GMP improvement plan. This progress is a result of our focus on improving manufacturing quality, which includes the substantial investments we have made since 2001," said Sidney Taurel, Lilly's chairman, president and chief executive officer. "However, we recognize that the initial progress was slower than we had hoped because we did not fully appreciate the scope of the issues until the end of 2001."
"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," added Taurel.
On March 6, 2001, Lilly received a warning letter from the FDA following a routine preapproval site inspection by the agency in February 2001 in connection with the company's application for approval of the rapid-acting intramuscular formulation of Zyprexa (Zyprexa IntraMuscular). On March 29, 2001, Lilly received an approvable letter for Zyprexa IntraMuscular from the FDA indicating that approval was subject to resolution of manufacturing issues, a preapproval site inspection at the Indianapolis injectable facility, and the completion of label negotiations. Final FDA approval of Zyprexa IntraMuscular is now contingent upon successfully completing a preapproval site inspection, if necessary.
On September 29, 2003, Lilly received an approvable letter for Cymbalta from the FDA indicating that approval was contingent upon resolution of manufacturing issues, a preapproval site inspection at the Indianapolis dry products facility, and the completion of label negotiations. Final FDA approval is now contingent upon completion of label negotiations and a preapproval site inspection. Based on resolution of these items as well as ensuring that sufficient inventory levels are in place to satisfy market demand, the company's best estimate for U.S. approval and launch is the summer of 2004.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.
This press release contains forward-looking statements that are based on management's current expectations, but actual results may differ materially due to various factors. There are significant risks and uncertainties in pharmaceutical research and development. There can be no guarantees with respect to pipeline products that the products will receive the necessary clinical and manufacturing regulatory approvals or that they will prove to be commercially successful. The company's results may also be affected by such factors as competitive developments affecting current growth products, rate of sales growth of recently launched products, the timing of anticipated regulatory approvals and launches of new products, other regulatory developments and litigation involving current and future products and manufacturing facilities, the impact of governmental actions regarding coverage and reimbursement for pharmaceuticals, and the impact of exchange rates. For additional information about the factors that affect the company's business, please see Exhibit 99 to the company's latest Form 10-Q filed August 2003. The company undertakes no duty to update forward-looking statements.
Cymbalta(TM) (duloxetine hydrochloride, Lilly)
Zyprexa(R) IntraMuscular (olanzapine, Lilly)SOURCE: Eli Lilly and Company
Eli Lilly and Company
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