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OSP finalist
Action period
  1. Summary Review

    Action date:
    FDA Application:
    NDA207981
    Drug:
    Lonsurf
    Active Ingredients:
    Tipiracil hydrochloride; trifluridine
    • ...CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207 9810rig15000 SUMMARY REVIEW...
    • ...Division Director Summary Review Date September 21, 2015 From Patricia Keegan Subject Division Director Siunmary Review...
  2. Letter

    Action date:
    FDA Application:
    NDA207970
    Drug:
    Cabazitaxel injection
    Active Ingredients:
    Cabazitaxel
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207970 TENTATIVE APPROVAL Actavis LLC Attention...
    • ...NDA 207970 Page 2 brought for infringement of one or more of the patents that were the subject of the paragraph IV certifications. This action must...
  3. Letter

    Action date:
    FDA Application:
    NDA207963
    Drug:
    Palonosetron hydrochloride
    Active Ingredients:
    Palonosetron hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207963 TENTATIVE APPROVAL Exela Pharma Sciences, LLC...
    • ...NDA 207963 Page 2 brought for infringement of one or more of the patents that were the subject of the paragraph IV certifications. This action must...
  4. Label

    Action date:
    FDA Application:
    NDA207960
    Drug:
    Quillichew er
    Active Ingredients:
    Methylphenidate hydrochloride
    • ...-----------------------WARNINGS AND PRECAUTIONS-----------------------­  Serious Cardiovascular Reactions: Sudden death has been reported...
    • ...FULL PRESCRIBING INFORMATION WARNING: ABUSE AND DEPENDENCE CNS stimulants, including QuilliChew ER, other methylphenidate-containing products...
  5. Letter

    Action date:
    FDA Application:
    NDA207960
    Drug:
    Quillichew er
    Active Ingredients:
    Methylphenidate hydrochloride
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207960 NDA APPROVAL Pfizer Inc. Attention: Lisha Cole...
    • ...NDA 207960 Page 2 CARTON AND IMMEDIATE CONTAINER LABELS We acknowledge your November 11, 2015, submission containing final printed carton...
  6. Label

    Action date:
    FDA Application:
    NDA207958
    Drug:
    Spritam
    Active Ingredients:
    Levetiracetam
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SPRITAM® safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Partial Onset Seizures SPRITAM is indicated as adjunctive therapy in the treatment...
  7. Letter

    Action date:
    FDA Application:
    NDA207958
    Drug:
    Spritam
    Active Ingredients:
    Levetiracetam
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207958/S-002 SUPPLEMENT APPROVAL Aprecia...
    • ...NDA 207958/S-002 Page 2 swallowing. If there is any medicine left in the cup, add a small volume of liquid to the cup, swirl gently, and swallow...
  8. Label

    Action date:
    FDA Application:
    NDA207958
    Drug:
    Spritam
    Active Ingredients:
    Levetiracetam
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SPRITAM® safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Partial Onset Seizures SPRITAM is indicated as adjunctive therapy in the treatment...
  9. Letter

    Action date:
    FDA Application:
    NDA207958
    Drug:
    Spritam
    Active Ingredients:
    Levetiracetam
    • ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 NDA 207958 NDA APPROVAL Aprecia Pharmaceuticals Company...
    • ...NDA 207958 Page 2 We have completed our review of this application, as amended. It is approved, effective on the date of this letter, for use...
  10. Label

    Action date:
    FDA Application:
    NDA207953
    Drug:
    Yondelis
    Active Ingredients:
    Trabectedin
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use YONDELIS® safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE YONDELIS® is indicated for the treatment of patients with unresectable or metastatic liposarcoma...