IRVINE, Calif., March 13 /PRNewswire-FirstCall/ -- Spectrum Pharmaceuticals, Inc. announced that it has filed its thirteenth Abbreviated New Drug Application (ANDA), which is for an injectable drug, with the U.S. Food and Drug Administration (FDA).
Spectrum Pharmaceuticals currently has nine other ANDAs that are under review at the FDA, including an ANDA with Paragraph IV certification for sumatriptan succinate injection, the generic form of GlaxoSmithKline’s Imitrex(R) injection.
As announced last month, Spectrum’s generic product line will be distributed by Par Pharmaceutical Companies, Inc. . Spectrum will receive certain milestone payments on achievement of regulatory approvals and the parties shall share the profits from the sale of Spectrum’s generic products. In addition, Par shall provide financial and legal support for the ongoing patent challenge for sumatriptan injection.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a specialty pharmaceutical company engaged in the business of acquiring, developing and commercializing prescription drug products for the treatment of cancer and other unmet medical needs. By leveraging its operational flexibility and regulatory proficiency, and using the extensive research and development capabilities of its strategic alliance partners, Spectrum has built a diversified portfolio of proprietary and generic drug products in various stages of development and regulatory approval. For more information, please visit our website at http://www.spectrumpharm.com .
Forward-looking statements
This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, the Company’s operational flexibility and regulatory proficiency, the extensive research and development capabilities of the Company’s strategic alliance partners, that Spectrum will receive milestone payments on achievement of regulatory approvals, that PAR will generate profits from the sale of Spectrum’s generic drugs and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that price and other competitive pressures may make the marketing and sale of our generic drugs not commercially feasible, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company’s reports filed with the Securities and Exchange Commission.
Contact: Dr. Rajesh C. Shrotriya Chairman, President and CEO (949) 743-9295
Spectrum Pharmaceuticals, Inc.
CONTACT: Dr. Rajesh C. Shrotriya, Chairman, President and CEO of SpectrumPharmaceuticals, Inc., +1-949-743-9295
Web site: http://www.spectrumpharm.com/
