Cell Therapeutics, Inc. (CTIC) Monday said the U.S. Food and Drug Administration completed its inspection of the facility at NerPharMa, which manufactures the company's drug pixantrone, and found the site in compliance and acceptable for continued manufacturing of the drug product.
NerPharMa is a pharmaceutical manufacturing company belonging to Nerviano Medical Sciences Srl, in Nerviano, Italy.
Cell Therapeutics has a New Drug Application, or NDA, under review with the FDA for pixantrone to treat relapsed/refractory aggressive non-Hodgkin's lymphoma.
As announced earlier, the FDA's Oncologic Drugs Advisory Committee would review the NDA for pixantrone on March 22 and the FDA is expected to make a final decision on approval by April 23.
Craig Philips, the company's President, 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."
CTIC closed Friday's regular trade at $0.8955, up $0.1055 or 13.35%, on 31.48 million shares. The stock added one cent in the extended trade.
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