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FDA Approves Brodalumab .. With Some Caveats

|Includes: Valeant Pharmaceuticals International, Inc. (VRX)

- Brodalumab Approved

- Black Label Required

- Will only be available through Risk Evaluation and Mitigation Strategy called "Siliq REMS Program"

Requirements (directly from FDA):

  • Prescribers must be certified with the program and counsel patients about this risk. Patients with new or worsening symptoms of depression or suicidality should be referred to a mental health professional, as appropriate.
  • Patients must sign a Patient-Prescriber Agreement Form and be made aware of the need to seek medical attention should they experience new or worsening suicidal thoughts or behavior, feelings of depression, anxiety or other mood changes.
  • Pharmacies must be certified with the program and must only dispense to patients who are authorized to receive Siliq.

Link to the article: www.fda.gov/NewsEvents/Newsroom/PressAnn...

-ppushu

Disclosure: I am/we are long VRX.