Disclaimer: This is an early beta prototype. If you find any error, with data or functionality, please let us know via this page.
OSP finalist
Action period
  1. Label

    Action date:
    FDA Application:
    NDA208341
    Drug:
    Epclusa
    Active Ingredients:
    Sofosbuvir; velpatasvir
    • ...--------------------------------CONTRAINDICATIONS-----------------------------­ EPCLUSA and ribavirin combination regimen is contraindicated...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE EPCLUSA is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV...
  2. Letter

    Action date:
    FDA Application:
    NDA208341
    Drug:
    Epclusa
    Active Ingredients:
    Sofosbuvir; velpatasvir
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208341 NDA APPROVAL Gilead Sciences, Inc. Attention...
    • ...NDA 208341 Page 2 The SPL will be accessible via publicly available labeling repositories. IMMEDIATE CONTAINER LABELS Submit final printed immediate...
  3. Label

    Action date:
    FDA Application:
    NDA208294
    Drug:
    Bevespi aerosphere
    Active Ingredients:
    Formoterol fumarate; glycopyrrolate
    • ...• HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BEVESPI AEROSPHERE safely and effectively...
    • ...7.4. Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, QTc Prolonging Drugs................................................................. 9...
  4. Letter

    Action date:
    FDA Application:
    NDA208294
    Drug:
    Bevespi aerosphere
    Active Ingredients:
    Formoterol fumarate; glycopyrrolate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208294 NDA APPROVAL Pearl Therapeutics, Inc. 4222...
    • ...NDA 208294 Page 2 CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit the content of labeling [21...
  5. Label

    Action date:
    FDA Application:
    NDA208289
    Drug:
    Akovaz
    Active Ingredients:
    Ephedrine sulfate
    • ...___________________ ADVERSE REACTIONS ___________________ HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE AKOVAZ (ephedrine sulfate injection) is indicated for the treatment of clinically important...
  6. Letter

    Action date:
    FDA Application:
    NDA208289
    Drug:
    Akovaz
    Active Ingredients:
    Ephedrine sulfate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208289 NDA APPROVAL Flamel Ireland Limited c/o...
    • ...NDA 208289 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the enclosed...
  7. Summary Review

    Action date:
    FDA Application:
    NDA208289
    Drug:
    Akovaz
    Active Ingredients:
    Ephedrine sulfate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2082890rig18000 SUMMARY REVIEW...
    • ...'5 Food and Drug Administration CENTER FOR DRUG EVALUATION AND RESEARCH Division of Anesthesia and Analgesia Products at,? 10903 New Hampshire Ave...
  8. Letter

    Action date:
    FDA Application:
    NDA208286
    Drug:
    Zenavod
    Active Ingredients:
    Doxycycline
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208286 TENTATIVE APPROVAL Dr. Reddy’s Laboratories...
    • ...NDA 208286 Page 2 In addition, you have notified the Agency that the patent owner and/or approved application holder has initiated a patent...
  9. Label

    Action date:
    FDA Application:
    NDA208277
    Drug:
    Fycompa
    Active Ingredients:
    Perampanel
    • ...mg (mild) and 4 mg (moderate) once daily at bedtime (2.4)  Severe Hepatic Impairment: Not recommended (2.4)  Severe Renal Impairment...
    • ...FULL PRESCRIBING INFORMATION WARNING: SERIOUS PSYCHIATRIC AND BEHAVIORAL REACTIONS  Serious or life-threatening psychiatric and behavioral adverse...
  10. Letter

    Action date:
    FDA Application:
    NDA208277
    Drug:
    Fycompa
    Active Ingredients:
    Perampanel
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 208277 NDA APPROVAL Eisai Inc. Attention: Heather...
    • ...NDA 208277 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS Submit final printed carton and immediate container labels that are identical to the carton...