Prescription medicine
Midostaurin Brand names: Rydapt
Midostaurin (Rydapt) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the midostaurin FDA label on DailyMed (effective June 8, 2026, Novartis Pharmaceuticals Corporation); the NDA 207997 record on Drugs@FDA; every midostaurin label on DailyMed.
Highlights of the record
FDA label of June 8, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageRYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.
Forms and strengths
- 25 mg
Liquid-filled capsule.
On the market
- Earliest approval on file
- April 28, 2017 Rydapt, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first April 29, 2024; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 2, 2030 Rydapt capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,943 through July 30, 2026
What is midostaurin used for?
From the label: indications and usageRYDAPT is a kinase inhibitor indicated for the treatment of adult patients with: Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. ( 1.1 ) Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML. Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL). […]
Conditions named in the indications of midostaurin's FDA labels, with every medicine labeled for each:
From other midostaurin labelsLeukemia, lymphoma and myeloma: Acute Myeloid Leukemia RYDAPT is indicated in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) …
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (RYDAPT), Novartis Pharmaceuticals Corporation, effective June 8, 2026 (SPL set 11fa3fc9-6776-49a6-b1c1-653f627c3e58), via openFDA; the full label on DailyMed
Is there a generic for midostaurin (Rydapt)?
The FDA approved the first generic midostaurin on April 29, 2024. 3 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 2 patents for Rydapt capsules, the last expiring on December 2, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2024 first generic approved
- 2030 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the midostaurin label say about other medicines?
The midostaurin label names 18 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name midostaurin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | Examples; Carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John’s wort b |
| Clarithromycin | drug interactions | Examples; Boceprevir, clarithromycin, cobicistat, conivaptan, danoprevir and ritonavir, diltiazem, elvitegravir and ritonavir, grapefruit juice a, idelalisib, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, nefazodone, nelfinavir, paritaprevir and ritonavir and (ombitasvir and/or … |
| Cobicistat | drug interactions | Examples; Boceprevir, clarithromycin, cobicistat, conivaptan, danoprevir and ritonavir, diltiazem, elvitegravir and ritonavir, grapefruit juice a, idelalisib, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, nefazodone, nelfinavir, paritaprevir and ritonavir and (ombitasvir and/or … |
| Cytarabine | warnings and precautions | … unapproved formulation of midostaurin in combination with chemotherapy, including anthracyclines, fludarabine, and cytarabine; these two patients were coadministered an azole antifungal (a strong CYP3A4 inhibitor), which may increase midostaurin concentrations and subsequently, the risk of toxicity [see Drug … |
| Diltiazem | drug interactions | Examples; Boceprevir, clarithromycin, cobicistat, conivaptan, danoprevir and ritonavir, diltiazem, elvitegravir and ritonavir, grapefruit juice a, idelalisib, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, nefazodone, nelfinavir, paritaprevir and ritonavir and (ombitasvir and/or … |
| Enzalutamide | drug interactions | Examples; Carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John’s wort b |
| Fludarabine | warnings and precautions | … received an unapproved formulation of midostaurin in combination with chemotherapy, including anthracyclines, fludarabine, and cytarabine; these two patients were coadministered an azole antifungal (a strong CYP3A4 inhibitor), which may increase midostaurin concentrations and subsequently, the risk of toxicity [see … |
| Idelalisib | drug interactions | Examples; Boceprevir, clarithromycin, cobicistat, conivaptan, danoprevir and ritonavir, diltiazem, elvitegravir and ritonavir, grapefruit juice a, idelalisib, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, nefazodone, nelfinavir, paritaprevir and ritonavir and (ombitasvir and/or … |
| Itraconazole | drug interactions | Examples; Boceprevir, clarithromycin, cobicistat, conivaptan, danoprevir and ritonavir, diltiazem, elvitegravir and ritonavir, grapefruit juice a, idelalisib, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, nefazodone, nelfinavir, paritaprevir and ritonavir and (ombitasvir and/or … |
| Ketoconazole | drug interactions | Examples; Boceprevir, clarithromycin, cobicistat, conivaptan, danoprevir and ritonavir, diltiazem, elvitegravir and ritonavir, grapefruit juice a, idelalisib, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, nefazodone, nelfinavir, paritaprevir and ritonavir and (ombitasvir and/or … |
| Mitotane | drug interactions | Examples; Carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John’s wort b |
| Nefazodone | drug interactions | Examples; Boceprevir, clarithromycin, cobicistat, conivaptan, danoprevir and ritonavir, diltiazem, elvitegravir and ritonavir, grapefruit juice a, idelalisib, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, nefazodone, nelfinavir, paritaprevir and ritonavir and (ombitasvir and/or … |
| Nelfinavir | drug interactions | Examples; Boceprevir, clarithromycin, cobicistat, conivaptan, danoprevir and ritonavir, diltiazem, elvitegravir and ritonavir, grapefruit juice a, idelalisib, indinavir and ritonavir, itraconazole, ketoconazole, lopinavir and ritonavir, nefazodone, nelfinavir, paritaprevir and ritonavir and (ombitasvir and/or … |
| Phenytoin | drug interactions | Examples; Carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John’s wort b |
Every other medicine the midostaurin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Posaconazole | drug interactions | … nelfinavir, paritaprevir and ritonavir and (ombitasvir and/or dasabuvir), posaconazole, ritonavir, saquinavir and ritonavir, tipranavir and ritonavir, troleandomycin, voriconazole |
| Rifampin | drug interactions | Examples; Carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John’s wort b |
| Ritonavir | drug interactions | Examples; Boceprevir, clarithromycin, cobicistat, conivaptan, danoprevir and ritonavir, diltiazem, elvitegravir and ritonavir, grapefruit juice a, idelalisib, indinavir and ritonavir, itraconazole … |
| Voriconazole | drug interactions | … saquinavir and ritonavir, tipranavir and ritonavir, troleandomycin, voriconazole |
Source: FDA drug label (RYDAPT), Novartis Pharmaceuticals Corporation, effective June 8, 2026 (SPL set 11fa3fc9-6776-49a6-b1c1-653f627c3e58), via openFDA; the full label on DailyMed
What do FAERS reports show for midostaurin?
The FDA Adverse Event Reporting System holds 1,943 reports that list midostaurin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 465 are coded as a death and 502 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as midostaurin?
37 other medicines are given the same way (oral) and in the same FDA class as midostaurin or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Bosutinib | Leukemia, lymphoma and myeloma | 3 labelers | n/a | No current entry |
| Ibrutinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Ponatinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Acalabrutinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Pirtobrutinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as midostaurin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to midostaurin
- 37 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Midostaurin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other