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OSP finalist
Action period
  1. Label

    Action date:
    FDA Application:
    BLA125559
    Drug:
    Praluent
    Active Ingredients:
    Alirocumab
    • ...HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PRALUENT safely and effectively. See full...
    • ...FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Primary Hyperlipidemia PRALUENT is indicated as an adjunct to diet and maximally tolerated...
  2. Letter

    Action date:
    FDA Application:
    BLA125559
    Drug:
    Praluent
    Active Ingredients:
    Alirocumab
    • ....+>""'~"~ ( ..lff!._ •+,~~t._ ~...(J DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Silver Spring MD 20993 BLA 125559 BLA...
    • ...BLA 125559 Page 2 (b) (4) 3. Assemble bulk pre-filled syringes and label and package pre-filled pens at Sanofi-Aventis Deutschland GmbH...