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Pharmaceutical industry

Spectrum Pharmaceuticals Submits Supplemental New Drug Application for FUSILEV Ready-to-Use Formulation

Strategic Insights

— 1 min read

Spectrum Pharmaceuticals, a biotechnology company focused on oncology, has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a Ready-to-Use formulation of FUSILEV (levoleucovorin) for Injection. This submission supports FUSILEV's use in colorectal cancer, which is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) action date of April 29, 2011. The FDA has up to 60 days to formally accept the submission.

Key Takeaways:

  • Spectrum Pharmaceuticals submitted a sNDA to the FDA for a Ready-to-Use formulation of FUSILEV (levoleucovorin) for Injection in support of its use in colorectal cancer.
  • The current FDA-approved indication for FUSILEV is for rescue after high-dose methotrexate therapy in osteosarcoma.
  • FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination, and of inadvertent overdosage of folic acid antagonists.
  • The new Ready-to-Use formulation will be more convenient for healthcare providers, requiring no reconstitution and being of a higher strength than the currently available lyophilized formulation.
  • The submission is made in accordance with the FDA's PDUFA action date of April 29, 2011.
  • Rajesh C. Shrotriya, MD, Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals, believes that the Ready-to-Use formulation will be more convenient for healthcare providers and easy to use.

Statistics:

  • Spectrum Pharmaceuticals submitted the sNDA to the FDA.
  • The current FDA-approved indication for FUSILEV is for rescue after high-dose methotrexate therapy in osteosarcoma.
  • FUSILEV has been marketed outside the United States by Wyeth, Sanofi-Aventis, Takeda, and others for more than 10 years.
  • The Ready-to-Use formulation has a higher strength than the currently available lyophilized formulation.
  • The submission is made in accordance with the FDA's PDUFA action date of April 29, 2011.

Sources:

  • Spectrum Pharmaceuticals (NasdaqGS: SPPI)
  • U.S. Food and Drug Administration (FDA)
  • NewsRx.com
  • Clinical Trials Week via NewsRx.com
  • Wyeth, Sanofi-Aventis, Takeda, and others.

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