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Cinryze 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 History and FDA Approval Process for Cinryze

DateArticle
Jun 21, 2018Approval Shire Announces FDA Approval for Label Expansion of Cinryze (C1 esterase inhibitor [human]) for Prevention of Attacks in Pediatric Hereditary Angioedema Patients
Oct 13, 2008Approval Cinryze Receives FDA Approval for Prophylaxis Against Hereditary Angioedema Attacks
May  6, 2008Lev Pharmaceuticals Announces Cinryze Complete Response SubmissionAccepted for Review by FDA
May  2, 2008Lev Announces FDA Advisory Committee Unanimously RecommendsApproval 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 ReviewCinryze (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 forCinryze

Further information

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