Manufacturing Concerns Cited in CRL for Luitpold

The FDA has handed Luitpold Pharmaceuticals a Complete Response Letter (CRL) on its NDA for Injectafer after a recent inspection raised concerns about the drugmaker’s Shirley, N.Y., manufacturing facility. Luitpold, which plans to produce Injectafer (ferric carboxymaltose injection) for the U.S. market at the Long Island plant, stressed that the CRL did not include any concerns about its NDA submission.
Drug GMP Report