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KedRAB FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved August 23, 2017)
Brand name: KedRAB
Generic name: rabies immunoglobulin human
Dosage form: Injection
Company: Kamada Ltd. and Kedrion S.p.A.
Treatment for: Rabies Prophylaxis

KedRAB [rabies immunoglobulin (human)] is a human plasma derived anti-rabies immunoglobulin indicated for post-exposure prophylaxis (PEP) of rabies infection.

Development timeline for KedRAB

Jun  2, 2021Approval Kedrion and Kamada Announce FDA Approval of KedRAB Label Update, Confirming Safety and Effectiveness in Children
Aug 25, 2017Approval FDA Approves KedRAB [rabies immune globulin (Human)] for Post-Exposure Prophylaxis of Rabies Infection
Sep  1, 2016Kamada and Kedrion Seek FDA Approval of Human Rabies Immunoglobulin as a Post-Exposure Treatment

Further information

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