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OSP finalist
Action period
  1. Summary Review

    Action date:
    FDA Application:
    NDA207589
    Drug:
    Enstilar
    Active Ingredients:
    Betamethasone dipropionate; calcipotriene
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 2075890rig15000 SUMMARY REVIEW...
    • ...Slumnary Review Enstilar (calcipotriene and betamethasone) foam Summary Review for Regulatory Action...
  2. Label

    Action date:
    FDA Application:
    NDA207561
    Drug:
    Genvoya
    Active Ingredients:
    Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use GENVOYA safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS...
  3. Letter

    Action date:
    FDA Application:
    NDA207561
    Drug:
    Genvoya
    Active Ingredients:
    Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207561/S-003 SUPPLEMENT APPROVAL Gilead Sciences...
    • ...NDA 207561/S-003 Page 2 The SPL will be accessible from publicly available labeling repositories. Also within 14 days, amend all pending supplemental...
  4. Label

    Action date:
    FDA Application:
    NDA207561
    Drug:
    Genvoya
    Active Ingredients:
    Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use GENVOYA safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS...
  5. Letter

    Action date:
    FDA Application:
    NDA207561
    Drug:
    Genvoya
    Active Ingredients:
    Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207561 NDA APPROVAL Gilead Sciences, Inc. Attention...
    • ...NDA 207561 Page 2 We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use...
  6. Summary Review

    Action date:
    FDA Application:
    NDA207561
    Drug:
    Genvoya
    Active Ingredients:
    Cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207 5610rig15000 SUMMARY REVIEW...
    • ...Division Director?s Review Decisional Review for NDA 207561 Date October 19, 2015 From Debra Birnkrant, MD. Subject Division Director...
  7. Label

    Action date:
    FDA Application:
    NDA207533
    Drug:
    Aristada
    Active Ingredients:
    Aripiprazole lauroxil
    • ...____________________ CONT RAINDICAT IONS ____________________ Known hypersensitivity to aripiprazole (4) HIGHLIGHTS OF PRESCRIBING INFORMATION...
    • ...Reference ID: 3973933...
  8. Letter

    Action date:
    FDA Application:
    NDA207533
    Drug:
    Aristada
    Active Ingredients:
    Aripiprazole lauroxil
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207533/S-003 SUPPLEMENT APPROVAL Alkermes, Inc...
    • ...NDA 207533/S-003 Page 2 CONTENT OF LABELING As soon as possible, but no later than 14 days from the date of this letter, submit the content...
  9. Label

    Action date:
    FDA Application:
    NDA207533
    Drug:
    Aristada
    Active Ingredients:
    Aripiprazole lauroxil
    • ...___________________ HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ARISTADA™ safely...
    • ...*Sections or subsections omitted from the full prescribing information   are not listed. 2 Reference ID: 3829516...
  10. Letter

    Action date:
    FDA Application:
    NDA207533
    Drug:
    Aristada
    Active Ingredients:
    Aripiprazole lauroxil
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207533 NDA APPROVAL Alkermes, Inc. Attention: Ann...
    • ...NDA 207533 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...