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Bristol-Myers gets CRL for daclatasvir NDA

  • The FDA issues a Complete Response Letter (CRL) to Bristol-Myers Squibb (BMY +0.2%) in response to its NDA for HCV drug daclatasvir in combination with other agents.
  • The company's initial daclatasvir NDA focused on its use in combination with asunaprevir. Considering BMY's withdrawal of asunaprevir in October, the FDA requests additional data for daclatasvir in combination with other antiviral agents for the treatment of HCV infection. BMY is in discussions with the agency about the scope of these data.
  • Previously: Bristol-Myers pulls hep C NDA
  • Previously: Bristol-Myers presents data on HCV Trio regimen

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