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fulphila

Generic: biosimilar to Neulasta

fulphila: sourced relationships with 1 company · 1 FDA decision.

fulphila evidence translation

What we can confirm

What it means

Source-backed records connect fulphila to MYL; that link alone does not prove the drug works.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

How could fulphila → MYL affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

Dated Pipeline Records (1)
CompanyDated record stage
Mylan II B.V. (MYL)
Reported 2018-06-04 · Current development: unknownSource
Approved
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE Fulphila is a leukocyte growth factor indicated to • Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1.1 ) Limitations of Use Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Recei(MYL)FDA ↗
BLA761075Type 5 - New Formulation or New ManufacturerStandardOtherInjectable

Frequently asked questions

Which companies have sourced relationships with fulphila?

fulphila has dated SEC/FDA relationship records for Mylan II B.V..

What is fulphila's latest FDA decision?

The most recent tracked FDA decision for fulphila is Approval for 1 INDICATIONS AND USAGE Fulphila is a leukocyte growth factor indicated to • Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. ( 1.1 ) Limitations of Use Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Recei, dated June 4, 2018.