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Cinryze Approval History

  • FDA approved: Yes (First approved October 10th, 2008)
  • Brand name: Cinryze
  • Generic name: C1 esterase inhibitor (Human)
  • Company: Lev Pharmaceuticals, Inc.
  • Treatment for: Angioedema

Cinryze is a C1-esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).

Development History and FDA Approval Process for Cinryze

Oct 13, 2008Approval Cinryze Receives FDA Approval for Prophylaxis Against Hereditary Angioedema Attacks
May  6, 2008Lev Pharmaceuticals Announces Cinryze Complete Response Submission Accepted for Review by FDA
May  2, 2008Lev Announces FDA Advisory Committee Unanimously Recommends Approval of Cinryze for Hereditary Angioedema
Apr 15, 2008Lev Pharmaceuticals Announces Submission of Complete Response to FDA for Cinryze for Hereditary Angioedema
Mar 13, 2008Lev Announces FDA's Blood Products Advisory Committee to Review Cinryze (C1 inhibitor)
Jan 31, 2008Lev Pharmaceuticals Receives Complete Response Letter for Cinryze
Oct 30, 2007Lev Pharmaceuticals Amends Cinryze BLA to Include Prophylactic Data
Oct  1, 2007Lev's Cinryze BLA Accepted for Filing by FDA
Jul 31, 2007Lev Pharmaceuticals Submits Biologics License Application for Cinryze

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