Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Cell Therapeutics (CTI) has said that the US FDA has completed inspection of the facility at NerPharMa (a pharma manufacturing company belonging to Nerviano Medical Sciences, in Nerviano, Italy).
Subscribe to our email newsletter
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.”