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Granix FDA Approval History

FDA Approved: Yes (First approved August 29, 2012)
Brand name: Granix
Generic name: tbo-filgrastim
Dosage form: Injection
Company: A-S Medication Solutions, LLC
Treatment for: Neutropenia Associated with Chemotherapy

Granix (tbo-filgrastim) is a leukocyte growth factor indicated for the reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

Development timeline for Granix

DateArticle
Aug  6, 2018Approval Teva Announces Updated Indication and Vial Presentation for Granix (tbo-filgrastim) Injection in United States
Dec 23, 2014Approval FDA Approves Teva’s Granix (tbo-filgrastim) Injection for Self-Administration
Aug 30, 2012Approval FDA Approves Tbo-filgrastim for Severe Neutropenia in Certain Cancer Patients
Feb  2, 2010Teva Announces FDA Accepts BLA for XM02
Dec  2, 2009Teva Announces the Submission of a Biologics License Application (BLA) for XM02 for the Treatment of Chemotherapy-Induced Neutropenia

See also

Granix (tbo-filgrastim) Consumer information

Further information

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