The FDA has completed its inspection of Cell Therapeutics, Inc.’s
(CTI) facility at NerPharMa, a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences in Nerviano, Italy. FDA found the site in compliance for continued manufacture of CTI’s pixantrone product. CTI’s NDA for pixantrone is currently under review to treat relapsed/refractory aggressive non-Hodgkin's lymphoma. The FDA is expected to make a final decision on approval by April 23rd.
“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.