Cell Therapeutics, Inc. (CTI) announced that the U.S. Food and Drug Administration (FDA) has completed its inspection of the facility at NerPharMa (a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy), which manufactures CTI’s drug pixantrone and has found the site in compliance and acceptable for continued manufacturing of the drug product. CTI has a New Drug Application (NDA) under review at the FDA for pixantrone to treat relapsed/refractory aggressive non-Hodgkin’s lymphoma. As previously announced, the FDA’s Oncologic Drugs Advisory Committee (ODAC) will review the NDA for pixantrone on March 22, 2010 and the FDA is expected to make a final decision on approval by April 23, 2010.
“FDA approval of the NerPharMa facility to manufacture our drug product is a major milestone in the drug approval process and we are pleased that our manufacturing partner is prepared to provide commercial supplies when pixantrone is approved,” said Craig W. Philips, President of CTI.
Date: March 8, 2010
Source: Cell Therapeutics, Inc.