← FDA DRUG APPROVALS

FDA BLA · BLA761179

RYLAZE

asparaginase erwinia chrysanthemi (recombinant)-rywn

Sponsor: JAZZ PHARMS

APPLICATION
BLA761179
TYPE
BLA
ORIGINAL APPROVAL
2021-06-30
LATEST ACTION
2024-04-15
ROUTE
INTRAMUSCULAR
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

RYLAZEPrescription
ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN 10MG/0.5ML · INJECTABLE · INTRAMUSCULAR

Approval history

2024-04-15Labeling · Supplement 7 · standard — Letter ↗AP
2022-11-18Efficacy · Supplement 1 · standard — Letter ↗AP
2021-07-15Labeling · Supplement 2 · standardAP
2021-06-30Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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