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OSP finalist
Action period
  1. Label

    Action date:
    FDA Application:
    NDA208692
    Drug:
    Cabometyx
    Active Ingredients:
    Cabozantinib s-malate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use CABOMETYX safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE CABOMETYX is indicated for the treatment of patients with advanced renal cell carcinoma (RCC...
  2. Letter

    Action date:
    FDA Application:
    NDA208692
    Drug:
    Cabometyx
    Active Ingredients:
    Cabozantinib s-malate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208692 NDA APPROVAL Exelixis, Inc. Attention: Lisa...
    • ...NDA 208692 Page 2 automated drug registration and listing system (eLIST), as described at http://www.fda.gov/ForIndustry/DataStandards...
  3. Label

    Action date:
    FDA Application:
    NDA208624
    Drug:
    Viekira xr
    Active Ingredients:
    Dasabuvir sodium; ombitasvir; paritaprevir; ritonavir
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VIEKIRA XR safely and effectively. See full...
    • ...14 CLINICAL STUDIES 14.1 Description of Clinical Trials 14.2 Clinical Trial Results in Adults with Chronic HCV Genotype 1a and 1b Infection...
  4. Letter

    Action date:
    FDA Application:
    NDA208624
    Drug:
    Viekira xr
    Active Ingredients:
    Dasabuvir sodium; ombitasvir; paritaprevir; ritonavir
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208624 NDA APPROVAL AbbVie, Inc. Attention: Sherie...
    • ...NDA 208624 Page 2 Content of labeling must be identical to the enclosed labeling (text for the package insert, text for the Medication Guide...
  5. Label

    Action date:
    FDA Application:
    NDA208573
    Drug:
    Venclexta
    Active Ingredients:
    Venetoclax
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use VENCLEXTA safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE VENCLEXTA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL...
  6. Letter

    Action date:
    FDA Application:
    NDA208573
    Drug:
    Venclexta
    Active Ingredients:
    Venetoclax
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208573 ACCELERATED APPROVAL AbbVie, Inc. Attention...
    • ...NDA 208573 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and container labels that are identical to the carton...
  7. Summary Review

    Action date:
    FDA Application:
    NDA208573
    Drug:
    Venclexta
    Active Ingredients:
    Venetoclax
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2085730rig1s000 SUMMARY REVIEW...
    • ...Division Director Summary Review for Regulatory Action Date (electronic stamp) From Ann. T. Farrell...
  8. Letter

    Action date:
    FDA Application:
    NDA208562
    Drug:
    Voriconazole
    Active Ingredients:
    Voriconazole
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208562 TENTATIVE APPROVAL Xellia Pharmaceuticals ApS...
    • ...NDA 208562 Page 2 relevant court order or judgment settlement, or licensing agreement, as appropriate. In addition to a safety update, the amendment...
  9. Label

    Action date:
    FDA Application:
    NDA208551
    Drug:
    Triferic
    Active Ingredients:
    Ferric pyrophosphate citrate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TRIFERIC safely and effectively. See full...
    • ...2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage Inspect Triferic solution in ampules for signs of precipitation prior to mixing...
  10. Letter

    Action date:
    FDA Application:
    NDA208551
    Drug:
    Triferic
    Active Ingredients:
    Ferric pyrophosphate citrate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208551 NDA APPROVAL Rockwell Medical, Inc. Attention...
    • ...NDA 208551 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the carton...