February 23, 2010 / 3:21 PM / 9 years ago

UPDATE 2-US warns Lilly over insulin ingredient production

* FDA finds problem with insulin ingredient production

* Agency asks for impact on Lilly’s Humalog insulin

* Lilly says no patient safety issues found

* Lilly shares down 1.2 percent (Adds Lilly comment; Updates shares)

By Lisa Richwine

WASHINGTON, Feb 23 (Reuters) - U.S. health officials have warned Eli Lilly and Co (LLY.N) about problems with the production of an ingredient used to make the company’s Humalog insulin, a letter released on Tuesday said.

Lilly said there were no implications for patients from problems uncovered during a July 2009 inspection at a manufacturing plant in Puerto Rico.

The drugmaker’s shares fell 1.2 percent to $34.07 on the New York Stock Exchange.

The Food and Drug Administration, in a Feb. 5 letter, said inspectors found deviations from manufacturing standards in the production of Lyspro Insulin Zinc Crystals.

The agency said the company “failed to adequately investigate critical deviations” in some batches and asked Lilly to evaluate the impact on production of Humalog, one of the company’s best-selling products.

Lilly’s initial response in August 2009 “lacks sufficient corrective action,” the FDA said in the letter.

Company spokesman Ed Sagebiel said Lilly had “assessed this matter and determined that there are no safety and efficacy implications for patients.”

“We are taking prompt action to address the agency’s concerns,” he said.

The FDA sends dozens of warning letters per year. Most issued raised in the letters are resolved without further action, but the letters can lead to product seizures or other penalties.

Full year 2009 sales of Humalog rose 13 percent to $1.96 billion.

The FDA posted the letter here. (Reporting by Lisa Richwine, editing by Gerald E. McCormick and Gunna Dickson) ((lisa.richwine@thomsonreuters.com; + 1 202 310 5691; www.twitter.com/ReutersLisaRx))

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below