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IRVINE--- Spectrum Pharmaceuticals Receives FDA Approval for Fluconazole Tablets |
| 9/29/2005 @ 9:46 AM
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Spectrum Pharmaceuticals, Inc. (NASDAQ:SPPI) today announced that today that it has received approval from the Office of Generic Drugs of the US Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) for fluconazole tablets. Fluconazole is a widely used anti-fungal agent. The branded product, Diflucan(R), is marketed by Pfizer Pharmaceuticals.
"With three generic products now approved and several more pending FDA review, we have gained valuable experience in both developing generic drugs and achieving regulatory approval," stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. "As we receive marketing approval of our more specialized generics over the next several years, we believe that we will demonstrate the benefits of pursuing this opportunity as a way to enhance the financial resources of this company. At this time, our sales expectations from our generic portfolio is relatively modest, but we believe that our longer-term outlook remains positive."
The ANDA for fluconazole is the second oral product filed by NeoJB, LLC, a joint venture between Spectrum and J.B. Life Science Overseas Ltd, a subsidiary of J.B. Chemicals & Pharmaceuticals (JBCPL).
Spectrum Pharmaceuticals currently has nine ANDAs that are pending at the FDA, which among others include ophthalmic drugs, injectable anticancer drugs, and an ANDA with Paragraph IV certification for sumatriptan succinate 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 www.spectrumpharm.com. |
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| Tuesday, September 30, 2008 |
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FOUNTAIN VALLEY--- D-Link Supports Computer Sciences' Research at University of California, Irvine Posted 3:00 PM PST
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| Wednesday, September 24, 2008 |
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NEWPORT BEACH--- Western & Southern Migrates from TriZetto’s ClaimFacts System to Facets Platform Posted 6:32 AM PST
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