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  6. Untitled Letters 2021
  1. Warning Letters and Notice of Violation Letters to Pharmaceutical Companies

Untitled Letters 2021

These letters are supplied by the CDER Freedom of Information Office and only covers Office of Prescription Drug Promotion's untitled letters.  The agency may have redacted or edited some of the letters to remove confidential information.   

Office of Prescription Drug Promotion 

Company / Individual Product / Issue Issued Date

Amgen

BLA 125031 NEULASTA® (pegfilgrastim) injection, for subcutaneous use 7/72021

Biohaven Pharmaceuticals

NDA 212728 NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use 3/8/2021

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