Galenica dropped as much as 6.7 percent, the biggest intraday decline since Aug. 9, and was down 6.3 percent at 539.5 Swiss francs as of 9:21 a.m., cutting the company’s market value to 3.51 billion francs ($3.54 billion).
The regulator’s decision was related to a factory in Shirley, New York, owned by Luitpold Pharmaceuticals, where Injectafer would be made for the U.S. market, Bern, Switzerland- based Galenica said in a statement today. The FDA didn’t ask for any additional information on the drug itself.
“During a recent inspection, deficiencies in the manufacturing facility were noted by the FDA inspectors,” Galenica said. “The FDA requires satisfactory resolution of these deficiencies before the application for Injectafer can be approved. Luitpold Pharmaceuticals is working closely with the FDA to resolve these deficiencies.”
Luitpold, a unit of Tokyo-based Daiichi Sankyo Co., holds U.S. marketing rights for Injectafer. The drug is sold outside the U.S. as Ferinject.
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