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fda_pgx_biomarker_table.json
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fda_pgx_biomarker_table.json
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{
"collectedOn": "2022-08-20T01:19:17.939Z",
"fdaContentCurrentDate": "08/11/2022",
"sourceUrl": "https://www.fda.gov/drugs/science-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling",
"tableHash": "b71f396e4f6e0da56932f3e4ac87d31c",
"table": [
{
"Drug": "Abacavir",
"Therapeutic Area": "Infectious Diseases",
"Biomarker": "HLA-B",
"Labeling Sections": "Boxed Warning, Dosage and Administration, Contraindications, Warnings and Precautions"
},
{
"Drug": "Abemaciclib (1)",
"Therapeutic Area": "Oncology",
"Biomarker": "ESR (Hormone Receptor)",
"Labeling Sections": "Indications and Usage, Adverse Reactions, Clinical Studies"
},
{
"Drug": "Abemaciclib (2)",
"Therapeutic Area": "Oncology",
"Biomarker": "ERBB2 (HER2)",
"Labeling Sections": "Indications and Usage, Adverse Reactions, Clinical Studies"
},
{
"Drug": "Abemaciclib (3)",
"Therapeutic Area": "Oncology",
"Biomarker": "MKI67",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Clinical Studies"
},
{
"Drug": "Abrocitinib",
"Therapeutic Area": "Dermatology",
"Biomarker": "CYP2C19",
"Labeling Sections": "Dosage and Administration, Use in Specific Populations, Clinical Pharmacology"
},
{
"Drug": "Ado-Trastuzumab Emtansine",
"Therapeutic Area": "Oncology",
"Biomarker": "ERBB2 (HER2)",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies"
},
{
"Drug": "Aducanumab-avwa",
"Therapeutic Area": "Neurology",
"Biomarker": "APOE",
"Labeling Sections": "Warnings and Precautions, Clinical Studies"
},
{
"Drug": "Afatinib",
"Therapeutic Area": "Oncology",
"Biomarker": "EGFR",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies"
},
{
"Drug": "Alectinib",
"Therapeutic Area": "Oncology",
"Biomarker": "ALK",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies"
},
{
"Drug": "Alglucosidase Alfa",
"Therapeutic Area": "Inborn Errors of Metabolism",
"Biomarker": "GAA",
"Labeling Sections": "Warnings and Precautions"
},
{
"Drug": "Allopurinol",
"Therapeutic Area": "Oncology",
"Biomarker": "HLA-B",
"Labeling Sections": "Warnings"
},
{
"Drug": "Alpelisib (1)",
"Therapeutic Area": "Oncology",
"Biomarker": "ERBB2 (HER2)",
"Labeling Sections": "Indication and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies"
},
{
"Drug": "Alpelisib (2)",
"Therapeutic Area": "Oncology",
"Biomarker": "ESR (Hormone Receptor)",
"Labeling Sections": "Indication and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies"
},
{
"Drug": "Alpelisib (3)",
"Therapeutic Area": "Oncology",
"Biomarker": "PIK3CA",
"Labeling Sections": "Indication and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies"
},
{
"Drug": "Amifampridine",
"Therapeutic Area": "Neurology",
"Biomarker": "NAT2",
"Labeling Sections": "Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology"
},
{
"Drug": "Amifampridine Phosphate",
"Therapeutic Area": "Neurology",
"Biomarker": "NAT2",
"Labeling Sections": "Dosage and Administration, Use in Specific Populations, Clinical Pharmacology"
},
{
"Drug": "Amitriptyline",
"Therapeutic Area": "Psychiatry",
"Biomarker": "CYP2D6",
"Labeling Sections": "Precautions"
},
{
"Drug": "Amivantamab-vmjw",
"Therapeutic Area": "Oncology",
"Biomarker": "EGFR",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies"
},
{
"Drug": "Amoxapine",
"Therapeutic Area": "Psychiatry",
"Biomarker": "CYP2D6",
"Labeling Sections": "Precautions"
},
{
"Drug": "Amphetamine",
"Therapeutic Area": "Psychiatry",
"Biomarker": "CYP2D6",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Anakinra",
"Therapeutic Area": "Rheumatology",
"Biomarker": "NLRP3",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies"
},
{
"Drug": "Anastrozole",
"Therapeutic Area": "Oncology",
"Biomarker": "ESR, PGR (Hormone Receptor)",
"Labeling Sections": "Indications and Usage, Adverse Reactions, Drug Interactions, Clinical Studies"
},
{
"Drug": "Anifrolumab-fnia",
"Therapeutic Area": "Rheumatology",
"Biomarker": "Gene Signature (IFN)",
"Labeling Sections": "Clinical Pharmacology, Clinical Studies"
},
{
"Drug": "Arformoterol (1)",
"Therapeutic Area": "Pulmonary",
"Biomarker": "UGT1A1",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Arformoterol (2)",
"Therapeutic Area": "Pulmonary",
"Biomarker": "CYP2D6",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Aripiprazole",
"Therapeutic Area": "Psychiatry",
"Biomarker": "CYP2D6",
"Labeling Sections": "Dosage and Administration, Use in Specific Populations, Clinical Pharmacology"
},
{
"Drug": "Aripiprazole Lauroxil",
"Therapeutic Area": "Psychiatry",
"Biomarker": "CYP2D6",
"Labeling Sections": "Dosage and Administration, Use in Specific Populations, Clinical Pharmacology"
},
{
"Drug": "Arsenic Trioxide",
"Therapeutic Area": "Oncology",
"Biomarker": "PML-RARA",
"Labeling Sections": "Indications and Usage, Clinical Studies"
},
{
"Drug": "Articaine and Epinephrine (1)",
"Therapeutic Area": "Anesthesiology",
"Biomarker": "G6PD",
"Labeling Sections": "Warnings and Precautions"
},
{
"Drug": "Articaine and Epinephrine (2)",
"Therapeutic Area": "Anesthesiology",
"Biomarker": "Nonspecific (Congenital Methemoglobinemia)",
"Labeling Sections": "Warnings and Precautions"
},
{
"Drug": "Asciminib",
"Therapeutic Area": "Oncology",
"Biomarker": "BCR-ABL1 (Philadelphia chromosome)",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies"
},
{
"Drug": "Atezolizumab (1)",
"Therapeutic Area": "Oncology",
"Biomarker": "CD274 (PD-L1)",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Pharmacology, Clinical Studies"
},
{
"Drug": "Atezolizumab (2)",
"Therapeutic Area": "Oncology",
"Biomarker": "Gene Signature (T-effector)",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Atezolizumab (3)",
"Therapeutic Area": "Oncology",
"Biomarker": "EGFR",
"Labeling Sections": "Indications and Usage, Adverse Reactions, Clinical Studies"
},
{
"Drug": "Atezolizumab (4)",
"Therapeutic Area": "Oncology",
"Biomarker": "ALK",
"Labeling Sections": "Indications and Usage, Adverse Reactions, Clinical Studies"
},
{
"Drug": "Atezolizumab (5)",
"Therapeutic Area": "Oncology",
"Biomarker": "BRAF",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies"
},
{
"Drug": "Atomoxetine",
"Therapeutic Area": "Psychiatry",
"Biomarker": "CYP2D6",
"Labeling Sections": "Dosage and Administration, Warnings and Precautions, Adverse Reactions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology"
},
{
"Drug": "Ascorbic Acid, PEG-3350, Potassium Chloride, Sodium Ascorbate, Sodium Chloride, and Sodium Sulfate",
"Therapeutic Area": "Gastroenterology",
"Biomarker": "G6PD",
"Labeling Sections": "Warnings and Precautions, Adverse Reactions"
},
{
"Drug": "Avapritinib (1)",
"Therapeutic Area": "Oncology",
"Biomarker": "PDGFRA",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Clinical Studies"
},
{
"Drug": "Avapritinib (2)",
"Therapeutic Area": "Oncology",
"Biomarker": "KIT",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Avatrombopag (1)",
"Therapeutic Area": "Hematology",
"Biomarker": "F2 (Prothrombin)",
"Labeling Sections": "Warnings and Precautions"
},
{
"Drug": "Avatrombopag (2)",
"Therapeutic Area": "Hematology",
"Biomarker": "F5 (Factor V Leiden)",
"Labeling Sections": "Warnings and Precautions"
},
{
"Drug": "Avatrombopag (3)",
"Therapeutic Area": "Hematology",
"Biomarker": "PROC",
"Labeling Sections": "Warnings and Precautions"
},
{
"Drug": "Avatrombopag (4)",
"Therapeutic Area": "Hematology",
"Biomarker": "PROS1",
"Labeling Sections": "Warnings and Precautions"
},
{
"Drug": "Avatrombopag (5)",
"Therapeutic Area": "Hematology",
"Biomarker": "SERPINC1 (Antithrombin III)",
"Labeling Sections": "Warnings and Precautions"
},
{
"Drug": "Avatrombopag (6)",
"Therapeutic Area": "Hematology",
"Biomarker": "CYP2C9",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Avelumab",
"Therapeutic Area": "Oncology",
"Biomarker": "CD274 (PD-L1)",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Azacitidine (1)",
"Therapeutic Area": "Oncology",
"Biomarker": "CBL",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Azacitidine (2)",
"Therapeutic Area": "Oncology",
"Biomarker": "PTPN11",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Azacitidine (3)",
"Therapeutic Area": "Oncology",
"Biomarker": "RAS",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Azathioprine (1)",
"Therapeutic Area": "Rheumatology",
"Biomarker": "TPMT",
"Labeling Sections": "Dosage and Administration, Warnings, Precautions, Drug Interactions, Adverse Reactions, Clinical Pharmacology"
},
{
"Drug": "Azathioprine (2)",
"Therapeutic Area": "Rheumatology",
"Biomarker": "NUDT15",
"Labeling Sections": "Dosage and Administration, Warnings, Precautions, Adverse Reactions, Clinical Pharmacology"
},
{
"Drug": "Belinostat",
"Therapeutic Area": "Oncology",
"Biomarker": "UGT1A1",
"Labeling Sections": "Dosage and Administration, Clinical Pharmacology"
},
{
"Drug": "Belzutifan (1)",
"Therapeutic Area": "Oncology",
"Biomarker": "CYP2C19",
"Labeling Sections": "Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology"
},
{
"Drug": "Belzutifan (2)",
"Therapeutic Area": "Oncology",
"Biomarker": "UGT2B17",
"Labeling Sections": "Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology"
},
{
"Drug": "Belzutifan (3)",
"Therapeutic Area": "Oncology",
"Biomarker": "VHL",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Binimetinib (1)",
"Therapeutic Area": "Oncology",
"Biomarker": "BRAF",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Studies"
},
{
"Drug": "Binimetinib (2)",
"Therapeutic Area": "Oncology",
"Biomarker": "UGT1A1",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Blinatumomab (1)",
"Therapeutic Area": "Oncology",
"Biomarker": "BCR-ABL1 (Philadelphia chromosome)",
"Labeling Sections": "Adverse Reactions, Clinical Studies"
},
{
"Drug": "Blinatumomab (2)",
"Therapeutic Area": "Oncology",
"Biomarker": "CD19",
"Labeling Sections": "Indications and Usage"
},
{
"Drug": "Boceprevir",
"Therapeutic Area": "Infectious Diseases",
"Biomarker": "IFNL3 (IL28B)",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Bosutinib",
"Therapeutic Area": "Oncology",
"Biomarker": "BCR-ABL1 (Philadelphia chromosome)",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Studies"
},
{
"Drug": "Brentuximab Vedotin (1)",
"Therapeutic Area": "Oncology",
"Biomarker": "ALK",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Brentuximab Vedotin (2)",
"Therapeutic Area": "Oncology",
"Biomarker": "TNFRSF8 (CD30)",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies"
},
{
"Drug": "Brexpiprazole",
"Therapeutic Area": "Psychiatry",
"Biomarker": "CYP2D6",
"Labeling Sections": "Dosage and Administration, Use in Specific Populations, Clinical Pharmacology"
},
{
"Drug": "Brigatinib",
"Therapeutic Area": "Oncology",
"Biomarker": "ALK",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies"
},
{
"Drug": "Brivaracetam",
"Therapeutic Area": "Neurology",
"Biomarker": "CYP2C19",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Bupivacaine (1)",
"Therapeutic Area": "Anesthesiology",
"Biomarker": "G6PD",
"Labeling Sections": "Warnings"
},
{
"Drug": "Bupivacaine (2)",
"Therapeutic Area": "Anesthesiology",
"Biomarker": "Nonspecific (Congenital Methemoglobinemia)",
"Labeling Sections": "Warnings"
},
{
"Drug": "Bupropion",
"Therapeutic Area": "Psychiatry",
"Biomarker": "CYP2D6",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Busulfan",
"Therapeutic Area": "Oncology",
"Biomarker": "BCR-ABL1 (Philadelphia chromosome)",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Cabotegravir and Rilpivirine (1)",
"Therapeutic Area": "Infectious Diseases",
"Biomarker": "HLA-B",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Cabotegravir and Rilpivirine (2)",
"Therapeutic Area": "Infectious Diseases",
"Biomarker": "UGT1A1",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Cabozantinib",
"Therapeutic Area": "Oncology",
"Biomarker": "RET",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Capmatinib",
"Therapeutic Area": "Oncology",
"Biomarker": "MET",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Clinical Studies"
},
{
"Drug": "Capecitabine",
"Therapeutic Area": "Oncology",
"Biomarker": "DPYD",
"Labeling Sections": "Warnings and Precautions, Patient Counseling Information"
},
{
"Drug": "Carbamazepine (1)",
"Therapeutic Area": "Neurology",
"Biomarker": "HLA-B",
"Labeling Sections": "Boxed Warning, Warnings, Precautions"
},
{
"Drug": "Carbamazepine (2)",
"Therapeutic Area": "Neurology",
"Biomarker": "HLA-A",
"Labeling Sections": "Warnings"
},
{
"Drug": "Carglumic Acid",
"Therapeutic Area": "Inborn Errors of Metabolism",
"Biomarker": "NAGS",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies"
},
{
"Drug": "Cariprazine",
"Therapeutic Area": "Psychiatry",
"Biomarker": "CYP2D6",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Carisoprodol",
"Therapeutic Area": "Rheumatology",
"Biomarker": "CYP2C19",
"Labeling Sections": "Use in Specific Populations, Clinical Pharmacology"
},
{
"Drug": "Carvedilol",
"Therapeutic Area": "Cardiology",
"Biomarker": "CYP2D6",
"Labeling Sections": "Drug Interactions, Clinical Pharmacology"
},
{
"Drug": "Casimersen",
"Therapeutic Area": "Neurology",
"Biomarker": "DMD",
"Labeling Sections": "Indications and Usage, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies"
},
{
"Drug": "Ceftriaxone (1)",
"Therapeutic Area": "Infectious Diseases",
"Biomarker": "G6PD",
"Labeling Sections": "Warnings"
},
{
"Drug": "Ceftriaxone (2)",
"Therapeutic Area": "Infectious Diseases",
"Biomarker": "Nonspecific (Congenital Methemoglobinemia)",
"Labeling Sections": "Warnings"
},
{
"Drug": "Celecoxib",
"Therapeutic Area": "Rheumatology",
"Biomarker": "CYP2C9",
"Labeling Sections": "Dosage and Administration, Use in Specific Populations, Clinical Pharmacology"
},
{
"Drug": "Cemiplimab-rwlc (1)",
"Therapeutic Area": "Oncology",
"Biomarker": "ALK",
"Labeling Sections": "Indications and Usage, Clinical Studies"
},
{
"Drug": "Cemiplimab-rwlc (2)",
"Therapeutic Area": "Oncology",
"Biomarker": "CD274 (PD-L1)",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Clinical Studies"
},
{
"Drug": "Cemiplimab-rwlc (3)",
"Therapeutic Area": "Oncology",
"Biomarker": "EGFR",
"Labeling Sections": "Indications and Usage, Clinical Studies"
},
{
"Drug": "Cemiplimab-rwlc (4)",
"Therapeutic Area": "Oncology",
"Biomarker": "ROS1",
"Labeling Sections": "Indications and Usage, Clinical Studies"
},
{
"Drug": "Ceritinib",
"Therapeutic Area": "Oncology",
"Biomarker": "ALK",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Warning and Precautions, Adverse Reactions, Clinical Studies"
},
{
"Drug": "Cerliponase Alfa",
"Therapeutic Area": "Inborn Errors of Metabolism",
"Biomarker": "TPP1",
"Labeling Sections": "Indications and Usage, Use in Specific Populations, Clinical Studies"
},
{
"Drug": "Cetuximab (1)",
"Therapeutic Area": "Oncology",
"Biomarker": "EGFR",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies"
},
{
"Drug": "Cetuximab (2)",
"Therapeutic Area": "Oncology",
"Biomarker": "RAS",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Studies"
},
{
"Drug": "Cetuximab (3)",
"Therapeutic Area": "Oncology",
"Biomarker": "BRAF",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies"
},
{
"Drug": "Cevimeline",
"Therapeutic Area": "Dental",
"Biomarker": "CYP2D6",
"Labeling Sections": "Precautions"
},
{
"Drug": "Chloroprocaine (1)",
"Therapeutic Area": "Anesthesiology",
"Biomarker": "G6PD",
"Labeling Sections": "Warnings"
},
{
"Drug": "Chloroprocaine (2)",
"Therapeutic Area": "Anesthesiology",
"Biomarker": "Nonspecific (Congenital Methemoglobinemia)",
"Labeling Sections": "Warnings"
},
{
"Drug": "Chloroquine",
"Therapeutic Area": "Infectious Diseases",
"Biomarker": "G6PD",
"Labeling Sections": "Precautions, Adverse Reactions"
},
{
"Drug": "Chlorpropamide",
"Therapeutic Area": "Endocrinology",
"Biomarker": "G6PD",
"Labeling Sections": "Precautions"
},
{
"Drug": "Cholic Acid",
"Therapeutic Area": "Inborn Errors of Metabolism",
"Biomarker": "AMACR, AKR1D1, CYP7A1, CYP27A1, DHCR7, HSD3B2 (Bile Acid Synthesis Disorders)",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Studies"
},
{
"Drug": "Cisplatin",
"Therapeutic Area": "Oncology",
"Biomarker": "TPMT",
"Labeling Sections": "Adverse Reactions"
},
{
"Drug": "Citalopram (1)",
"Therapeutic Area": "Psychiatry",
"Biomarker": "CYP2C19",
"Labeling Sections": "Dosage and Administration, Warnings, Clinical Pharmacology"
},
{
"Drug": "Citalopram (2)",
"Therapeutic Area": "Psychiatry",
"Biomarker": "CYP2D6",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Clobazam",
"Therapeutic Area": "Neurology",
"Biomarker": "CYP2C19",
"Labeling Sections": "Dosage and Administration, Use in Specific Populations, Clinical Pharmacology"
},
{
"Drug": "Clomipramine",
"Therapeutic Area": "Psychiatry",
"Biomarker": "CYP2D6",
"Labeling Sections": "Precautions"
},
{
"Drug": "Clopidogrel",
"Therapeutic Area": "Cardiology",
"Biomarker": "CYP2C19",
"Labeling Sections": "Boxed Warning, Warnings and Precautions, Clinical Pharmacology"
},
{
"Drug": "Clozapine",
"Therapeutic Area": "Psychiatry",
"Biomarker": "CYP2D6",
"Labeling Sections": "Dosage and Administration, Use in Specific Populations, Clinical Pharmacology"
},
{
"Drug": "Cobimetinib",
"Therapeutic Area": "Oncology",
"Biomarker": "BRAF",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies"
},
{
"Drug": "Codeine",
"Therapeutic Area": "Anesthesiology",
"Biomarker": "CYP2D6",
"Labeling Sections": "Boxed Warning, Warnings and Precautions, Use in Specific Populations, Patient Counseling Information"
},
{
"Drug": "Crizanlizumab-tmca",
"Therapeutic Area": "Hematology",
"Biomarker": "HBB",
"Labeling Sections": "Adverse Reactions, Clinical Studies"
},
{
"Drug": "Crizotinib (1)",
"Therapeutic Area": "Oncology",
"Biomarker": "ALK",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies"
},
{
"Drug": "Crizotinib (2)",
"Therapeutic Area": "Oncology",
"Biomarker": "ROS1",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies"
},
{
"Drug": "Dabrafenib (1)",
"Therapeutic Area": "Oncology",
"Biomarker": "BRAF",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies"
},
{
"Drug": "Dabrafenib (2)",
"Therapeutic Area": "Oncology",
"Biomarker": "G6PD",
"Labeling Sections": "Warnings and Precautions, Adverse Reactions, Patient Counseling Information"
},
{
"Drug": "Dabrafenib (3)",
"Therapeutic Area": "Oncology",
"Biomarker": "RAS",
"Labeling Sections": "Dosage and Administration, Warnings and Precautions"
},
{
"Drug": "Daclatasvir",
"Therapeutic Area": "Infectious Diseases",
"Biomarker": "IFNL3 (IL28B)",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Dacomitinib",
"Therapeutic Area": "Oncology",
"Biomarker": "EGFR",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Studies"
},
{
"Drug": "Dapsone (1)",
"Therapeutic Area": "Dermatology",
"Biomarker": "G6PD",
"Labeling Sections": "Warnings and Precautions, Use in Specific Populations, Patient Counseling Information"
},
{
"Drug": "Dapsone (2)",
"Therapeutic Area": "Dermatology",
"Biomarker": "Nonspecific (Congenital Methemoglobinemia)",
"Labeling Sections": "Warnings and Precautions, Adverse Reactions, Patient Counseling Information"
},
{
"Drug": "Dapsone (3)",
"Therapeutic Area": "Infectious Diseases",
"Biomarker": "G6PD",
"Labeling Sections": "Precautions, Adverse Reactions, Overdosage"
},
{
"Drug": "Darifenacin",
"Therapeutic Area": "Urology",
"Biomarker": "CYP2D6",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Dasabuvir, Ombitasvir, Paritaprevir, and Ritonavir",
"Therapeutic Area": "Infectious Diseases",
"Biomarker": "IFNL3 (IL28B)",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Dasatinib",
"Therapeutic Area": "Oncology",
"Biomarker": "BCR-ABL1 (Philadelphia chromosome)",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Studies"
},
{
"Drug": "Denileukin Diftitox",
"Therapeutic Area": "Oncology",
"Biomarker": "IL2RA (CD25 antigen)",
"Labeling Sections": "Indications and Usage, Clinical Studies"
},
{
"Drug": "Desipramine",
"Therapeutic Area": "Psychiatry",
"Biomarker": "CYP2D6",
"Labeling Sections": "Precautions"
},
{
"Drug": "Desflurane",
"Therapeutic Area": "Anesthesiology",
"Biomarker": "Nonspecific (Genetic Susceptibility to Malignant Hyperthermia)",
"Labeling Sections": "Contraindications"
},
{
"Drug": "Desvenlafaxine",
"Therapeutic Area": "Psychiatry",
"Biomarker": "CYP2D6",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Deutetrabenazine",
"Therapeutic Area": "Neurology",
"Biomarker": "CYP2D6",
"Labeling Sections": "Dosage and Administration, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology"
},
{
"Drug": "Dexlansoprazole",
"Therapeutic Area": "Gastroenterology",
"Biomarker": "CYP2C19",
"Labeling Sections": "Drug Interactions, Clinical Pharmacology"
},
{
"Drug": "Dextromethorphan and Quinidine",
"Therapeutic Area": "Neurology",
"Biomarker": "CYP2D6",
"Labeling Sections": "Warnings and Precautions, Clinical Pharmacology"
},
{
"Drug": "Diazepam",
"Therapeutic Area": "Neurology",
"Biomarker": "CYP2C19",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Dinutuximab",
"Therapeutic Area": "Oncology",
"Biomarker": "MYCN",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Docetaxel",
"Therapeutic Area": "Oncology",
"Biomarker": "ESR, PGR (Hormone Receptor)",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Dolutegravir",
"Therapeutic Area": "Infectious Diseases",
"Biomarker": "UGT1A1",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Donepezil",
"Therapeutic Area": "Neurology",
"Biomarker": "CYP2D6",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Dostarlimab-gxly",
"Therapeutic Area": "Oncology",
"Biomarker": "Mismatch Repair",
"Labeling Sections": "Indication and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies"
},
{
"Drug": "Doxepin (1)",
"Therapeutic Area": "Psychiatry",
"Biomarker": "CYP2D6",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Doxepin (2)",
"Therapeutic Area": "Psychiatry",
"Biomarker": "CYP2C19",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Dronabinol",
"Therapeutic Area": "Gastroenterology",
"Biomarker": "CYP2C9",
"Labeling Sections": "Use in Specific Populations, Clinical Pharmacology"
},
{
"Drug": "Drospirenone and Ethinyl Estradiol",
"Therapeutic Area": "Gynecology",
"Biomarker": "CYP2C19",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Duloxetine",
"Therapeutic Area": "Psychiatry",
"Biomarker": "CYP2D6",
"Labeling Sections": "Drug Interactions"
},
{
"Drug": "Durvalumab",
"Therapeutic Area": "Oncology",
"Biomarker": "CD274 (PD-L1)",
"Labeling Sections": "Clinical Pharmacology, Clinical Studies"
},
{
"Drug": "Duvelisib",
"Therapeutic Area": "Oncology",
"Biomarker": "Chromosome 17p",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Eculizumab (1)",
"Therapeutic Area": "Neurology",
"Biomarker": "ACHR",
"Labeling Sections": "Indications and Usage, Clinical Studies"
},
{
"Drug": "Eculizumab (2)",
"Therapeutic Area": "Neurology",
"Biomarker": "AQP4",
"Labeling Sections": "Indications and Usage, Clinical Studies"
},
{
"Drug": "Efavirenz",
"Therapeutic Area": "Infectious Diseases",
"Biomarker": "CYP2B6",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Efgartigimod Alfa-fcab",
"Therapeutic Area": "Neurology",
"Biomarker": "ACHR",
"Labeling Sections": "Indications and Usage, Clinical Pharmacology, Clinical Studies"
},
{
"Drug": "Elagolix",
"Therapeutic Area": "Gynecology",
"Biomarker": "SLCO1B1",
"Labeling Sections": "Clinical Pharmacology"
},
{
"Drug": "Elbasvir and Grazoprevir",
"Therapeutic Area": "Infectious Diseases",
"Biomarker": "IFNL3 (IL28B)",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Elexacaftor, Ivacaftor, and Tezacaftor",
"Therapeutic Area": "Pulmonary",
"Biomarker": "CFTR",
"Labeling Sections": "Indications and Usage, Use in Specific Populations, Clinical Pharmacology, Clinical Studies"
},
{
"Drug": "Eliglustat",
"Therapeutic Area": "Inborn Errors of Metabolism",
"Biomarker": "CYP2D6",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Contraindications, Warnings and Precautions, Drug Interactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies"
},
{
"Drug": "Elosulfase",
"Therapeutic Area": "Inborn Errors of Metabolism",
"Biomarker": "GALNS",
"Labeling Sections": "Indications and Usage, Warnings and Precautions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies"
},
{
"Drug": "Eltrombopag (1)",
"Therapeutic Area": "Hematology",
"Biomarker": "F5 (Factor V Leiden)",
"Labeling Sections": "Warnings and Precautions"
},
{
"Drug": "Eltrombopag (2)",
"Therapeutic Area": "Hematology",
"Biomarker": "SERPINC1 (Antithrombin III)",
"Labeling Sections": "Warnings and Precautions"
},
{
"Drug": "Eltrombopag (3)",
"Therapeutic Area": "Hematology",
"Biomarker": "Chromosome 7",
"Labeling Sections": "Adverse Reactions"
},
{
"Drug": "Eltrombopag (4)",
"Therapeutic Area": "Hematology",
"Biomarker": "Chromosome 13",
"Labeling Sections": "Adverse Reactions"
},
{
"Drug": "Emapalumab-lzsg",
"Therapeutic Area": "Hematology",
"Biomarker": "PRF1, RAB27A, SH2D1A, STXBP2, STX11, UNC13D, XIAP (Hemophagocytic Lymphohistiocytosis)",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Enasidenib",
"Therapeutic Area": "Oncology",
"Biomarker": "IDH2",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies"
},
{
"Drug": "Encorafenib (1)",
"Therapeutic Area": "Oncology",
"Biomarker": "BRAF",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies"
},
{
"Drug": "Encorafenib (2)",
"Therapeutic Area": "Oncology",
"Biomarker": "RAS",
"Labeling Sections": "Dosage and Administration, Warnings and Precautions, Clinical Studies"
},
{
"Drug": "Enfortumab Vedotin-ejfv",
"Therapeutic Area": "Oncology",
"Biomarker": "NECTIN4",
"Labeling Sections": "Clinical Studies"
},
{
"Drug": "Entrectinib (1)",
"Therapeutic Area": "Oncology",
"Biomarker": "ROS1",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies"
},
{
"Drug": "Entrectinib (2)",
"Therapeutic Area": "Oncology",
"Biomarker": "NTRK",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Adverse Reactions, Use in Specific Populations, Clinical Pharmacology, Clinical Studies"
},
{
"Drug": "Erdafitinib (1)",
"Therapeutic Area": "Oncology",
"Biomarker": "FGFR",
"Labeling Sections": "Indications and Usage, Dosage and Administration, Adverse Reactions, Clinical Studies, Patient Counseling Information"
},
{
"Drug": "Erdafitinib (2)",
"Therapeutic Area": "Oncology",
"Biomarker": "CYP2C9",