This reference hub prioritizes regulatory and authoritative sources.
Regulatory sources
U.S. Food and Drug Administration
The FDA prescribing information provides current U.S. indications, dosage, warnings, adverse reactions, interactions and clinical pharmacology.
DailyMed
DailyMed provides the current U.S. ICLUSIG label record and identifies Takeda Pharmaceuticals America, Inc. as the packager for the listed product.
European Medicines Agency
The EMA EPAR provides European authorization information, indications, safety information and regulatory history for Iclusig.
Original development
FDA historical documents identify ARIAD Pharmaceuticals, Inc. as the applicant for the original Iclusig NDA.
Ponaxen-specific information
The manufacturer, authorization status and official regulatory documentation for Ponaxen are Everest Pharmaceuticals Ltd.
References for clinical evidence
The FDA clinical pharmacology review and EMA assessment documentation provide additional information about ponatinib’s development and clinical evidence.