May 1, 2008 - Pro-Pharmaceuticals, Inc., a Company developing targeted therapeutic compounds to treat cancer and fibrosis, today announced the receipt of the manufacturing and certification data for DAVANAT(R) from SAFC(R), the custom manufacturing services division of Sigma-Aldrich(TM) (Nasdaq: SIAL). The manufacturing and validation data is under final independent audit and is needed for registration of a pharmaceutical ingredient. The Company plans to submit the Drug Master File (DMF) shortly to the U.S. Food and Drug Administration (FDA). The DMF submission is an important step in the Company's plan to file a New Drug Application (NDA) for DAVANAT(R) later this year.
The FDA responded in a letter last year to questions from the Company to discuss the submission of an NDA for DAVANAT(R) to treat cancer patients. The FDA recommended that the Company provide the chemistry, manufacturing and controls (CMC) information necessary to support an NDA submission.
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