Cinryze FDA Approval History
FDA Approved: Yes (First approved October 10, 2008)
Brand name: Cinryze
Generic name: C1 esterase inhibitor (human)
Dosage form: Injection
Company: Shire plc
Treatment for: Hereditary Angioedema
Cinryze is a C1-esterase inhibitor indicated for routine prophylaxis against angioedema attacks in patients with hereditary angioedema (HAE).
Development timeline for Cinryze
Date | Article |
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Jun 21, 2018 | Approval Shire Announces FDA Approval for Label Expansion of Cinryze (C1 esterase inhibitor [human]) for Prevention of Attacks in Pediatric Hereditary Angioedema Patients |
Oct 13, 2008 | Approval Cinryze Receives FDA Approval for Prophylaxis Against Hereditary Angioedema Attacks |
May 6, 2008 | Lev Pharmaceuticals Announces Cinryze Complete Response SubmissionAccepted for Review by FDA |
May 2, 2008 | Lev Announces FDA Advisory Committee Unanimously RecommendsApproval of Cinryze for Hereditary Angioedema |
Apr 15, 2008 | Lev Pharmaceuticals Announces Submission of Complete Response to
FDA for Cinryze for Hereditary Angioedema |
Mar 13, 2008 | Lev Announces FDA's Blood Products Advisory Committee to ReviewCinryze (C1 inhibitor) |
Jan 31, 2008 | Lev Pharmaceuticals Receives Complete Response Letter for Cinryze |
Oct 30, 2007 | Lev Pharmaceuticals Amends Cinryze BLA to Include Prophylactic Data |
Oct 1, 2007 | Lev's Cinryze BLA Accepted for Filing by FDA |
Jul 31, 2007 | Lev Pharmaceuticals Submits Biologics License Application forCinryze |
Further information
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