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U.S. FDA Approves Mylan’s Semglee Insulin Product

June 11, 2020, 4:52 PM

Mylan’s Semglee was approved by the U.S. Food and Drug Administration, with indications that it can improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus, the agency said in an e-mailed statement.

  • The approved NDA was deemed to be an approved biologics license application and can therefore be a reference product for a proposed insulin glargine biosimilar or interchangeable biosimilar product

To contact the reporter on this story:
Greg Chang in San Francisco at gchang1@bloomberg.net

To contact the editor responsible for this story:
Chakradhar Adusumilli at cadusumilli@bloomberg.net

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