NerPharMa 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. The FDA’s Oncologic Drugs Advisory Committee (ODAC) is expected to 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.
Craig Philips, president of CTI, said: “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.”