Galenica's U.S. partner, Luitpold Pharmaceuticals, Inc., has received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Application for the intravenous iron preparation Injectafer®. In the Complete Response Letter the FDA noted its decision to withhold approval at this time. The decision was not related to any issues with the Injectafer® NDA filing, but with Luitpold's manufacturing facility in Shirley, New York, where Injectafer® would be manufactured for the US market.
On 30 September 2011, Luitpold Pharmaceuticals, Inc., a company of the Japanese Daiichi Sankyo Group, had submitted a New Drug Application (NDA)
On 30 September 2011, Luitpold Pharmaceuticals, Inc., a company of the Japanese Daiichi Sankyo Group, had submitted a New Drug Application (NDA)
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