Bavarian Nordic — Marts 2020
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Zealand Pharma submits New Drug Application to the U.S. Food and Drug Administration for the Dasiglucagon HypoPal Rescue Pen for treatment of severe hypoglycemia
The Dasiglucagon HypoPal Rescue Pen New Drug Application represents a major milestone in Zealand Pharmas efforts to bring life changing therapies to people with diabetes
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The submission encompasses three Phase 3 trials which met all primary and key secondary endpoints with a median time to recovery from hypoglycemia of only 10 minutes
Zealand Pharma remains on-track to build commercial infrastructure in the U.S. for the anticipated Dasiglucagon HypoPal Rescue Pen launch in 2021
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Hypopal anvendes til nødbehandling af diabetikere i forbindelse med for lavt blodsukkerniveauer.
Pennen er baseret på lægemiddelkandidaten Dasiglucagon, der skal bruges til behandling af episoder med for lavt blodsukker hos diabetikere - såkaldt hypoglykæmi.
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PDUFA Date:
https://www.fool.com/knowledge-center/what-is-a-pdufa-date.aspx
PDUFA drug approval dates:
https://www.fdatracker.com/fda-calendar/ -
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