Rochester, NY 7/10/2009 11:10:44 PM
Stock Exchange News - SPPI - SPPI Presented Formal Response to FDA Regarding Supplemental Biologics License Application - Sourced WhisperFromWallStreet.com
Spectrum Pharmaceuticals, Inc.
Stock Exchange News - SPPI - SPPI Presented Formal Response to FDA Regarding Supplemental Biologics License Application - Sourced WhisperFromWallStreet.com
COMPANY - Spectrum Pharmaceuticals, Inc.,SPPI
NEWS - Spectrum Pharmaceuticals, a commercial-stage biotechnology company with a focus in oncology, today announced that it has responded to and submitted on Wednesday, July 8, 2009, a formal response to the Complete Response letter it received from the U.S. Food and Drug Administration (FDA) on Thursday, July 2, 2009 regarding its supplemental Biologics License Application (sBLA) for ZEVALIN® (ibritumomab tiuxetan) in the first-line consolidation setting for non-Hodgkin’s Lymphoma (NHL) patients. It was received by the FDA on Wednesday afternoon. ZEVALIN is currently FDA approved and marketed by Spectrum for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell NHL, including patients who have rituximab-refractory follicular NHL.We believe that the data we submitted will satisfy the requirements of the FDA,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “We continue to expect a favorable regulatory decision.”
Real-Time: 5.07 Down 0.16 (3.06%) 11:30AM ET
Last Trade: 5.11
Day's Range: 5.08 - 5.20
52wk Range: 0.55 - 8.15
Volume: 370,149
ABOUT - Spectrum Pharmaceuticals, Inc., a commercial-stage biotechnology company with a focus on oncology, develops and commercializes a portfolio of drug products. Its marketed products include ZEVALIN, a form of cancer therapy called radioimmunotherapy for the treatment of non-Hodgkin's Lymphoma (NHL); and FUSILEV, which is indicated after high-dose methotrexate therapy in patients with osteosarcoma. The company is also developing apaziquone for the treatment of non-muscle invasive bladder cancer. Its phase II products include Ozarelix, a drug being investigated for benign prostatic hypertrophy (BPH), a non-cancerous enlargement of the prostate, and hormone dependent prostate cancer; and Ortataxel, a third-generation taxane.
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