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OSP finalist
Action period
  1. Label

    Action date:
    FDA Application:
    NDA208547
    Drug:
    Netspot
    Active Ingredients:
    Gallium dotatate ga-68
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NETSPOT safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE NETSPOT, after radiolabeling with Ga 68, is indicated for use with positron emission tomography...
  2. Letter

    Action date:
    FDA Application:
    NDA208547
    Drug:
    Netspot
    Active Ingredients:
    Gallium dotatate ga-68
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208547 NDA APPROVAL Advanced Accelerator...
    • ...NDA 208547 Page 2 Container label, Syringe label and Carton labeling: • Ensure that the font size of the established name is at least ½ the size...
  3. Summary Review

    Action date:
    FDA Application:
    NDA208547
    Drug:
    Netspot
    Active Ingredients:
    Gallium dotatate ga-68
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2085470rig1s000 SUMMARY REVIEW...
    • ...Division Director Summary Review NDA 208547, NETSPOT (Kit for 68Ga- DOTATATE) Libero Marzella MD, Division Director Summary Review for Regulatory...
  4. Label

    Action date:
    FDA Application:
    NDA208524
    Drug:
    Belviq xr
    Active Ingredients:
    Lorcaserin hydrochloride
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BELVIQ XR safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE BELVIQ XR (lorcaserin hydrochloride) extended-release tablet is indicated as an adjunct...
  5. Letter

    Action date:
    FDA Application:
    NDA208524
    Drug:
    Belviq xr
    Active Ingredients:
    Lorcaserin hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208524 NDA APPROVAL Arena Pharmaceuticals, Inc. Attn...
    • ...NDA 208524 Page 2 printed. Please submit these labels electronically according to the guidance for industry Providing Regulatory Submissions...
  6. Label

    Action date:
    FDA Application:
    NDA208471
    Drug:
    Adlyxin
    Active Ingredients:
    Lixisenatide
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ADLYXIN safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE ADLYXIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults...
  7. Letter

    Action date:
    FDA Application:
    NDA208471
    Drug:
    Adlyxin
    Active Ingredients:
    Lixisenatide
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208471 NDA APPROVAL Sanofi US Services Inc. Attention...
    • ...NDA 208471 Page 2 after they are printed. Please submit these labels electronically according to the guidance for industry Providing Regulatory...
  8. Label

    Action date:
    FDA Application:
    NDA208462
    Drug:
    Ninlaro
    Active Ingredients:
    Ixazomib citrate
    • ...Page 1 of 23  HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NINLARO safely and effectively...
    • ...Page 2 of 23  FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE NINLARO is indicated in combination with lenalidomide and dexamethasone...
  9. Letter

    Action date:
    FDA Application:
    NDA208462
    Drug:
    Ninlaro
    Active Ingredients:
    Ixazomib citrate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208462 NDA APPROVAL Millennium Pharmaceuticals, Inc...
    • ...NDA 208462 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the enclosed...
  10. Summary Review

    Action date:
    FDA Application:
    NDA208462
    Drug:
    Ninlaro
    Active Ingredients:
    Ixazomib citrate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2084620rig15000 SUMMARY REVIEW...
    • ...Summary Review for Regulatory Action Date (electronic stamp) From Ann. T. Farrell, M.D., Division Director Subject...