Food and Drug Administration (FDA) has issued a complete response letter to the company's supplemental Biologics License Application regarding PEGINTRONA; (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete lymphadenectomy.
The FDA has accepted for filing and review, and has granted priority review status for a supplemental Biologics License Application (sBLA) for use of Zevalin as consolidation therapy in patients with follicular B-cell non-Hodgkin's lymphoma who achieve a response to first-line therapy and expects a decision regarding the sBLA in early April, 2009.
Foodand Drug Administration (FDA) has approved an efficacy supplemental biologics license application (sBLA) for ONTAK' (denileukin diftitox) solution for intravenous injection for the treatment of patients with persistent or recurrent cutaneous T-celllymphoma (CTCL) whose malignant cells express the CD25 component of the interleukin (IL)-2 receptor (CD25+).
Food and Drug Administration (FDA) has issued a complete response letter to the company's supplemental Biologics License Application regarding PEGINTRONA; (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete lymphadenectomy.
In an announcement dated October 4, 2005, Abbott Laboratories announced it has simultaneously submitted a supplemental Biologics License Application with the US Food and Drug Administration (FDA) and a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA as a treatment for ankylosing spondylitis, an inflammatory disease of the spine and spinal joints.
ZEVALIN Supplemental Biologics License Application is Currently Under Review by the FDA for Use in the First-Line Consolidation Setting for Non-Hodgkin's Lymphoma (NHL) Patients * ZEVALIN is Currently FDA Approved and Marketed by Spectrum for Patients with Relapsed or Refractory, Low-Grade or Follicular B-Cell Non-Hodgkin's Lymphoma, Including Patients Who Have Rituximab-Refractory Follicular NHL IRVINE, Calif.
We believe that approval of the supplemental Biologics License Application (sBLA) for first-line consolidation therapy, which is based on the Phase 3 FIT data, anticipated regulatory and reimbursement changes, combined with our marketing efforts, will substantially improve patient access to ZEVALIN.
