| Cytarabine | US FDA | — | Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia. | approved | Jun 4, 1990 | openfda |
| Daunorubicin | US FDA | — | Daunorubicin hydrochloride in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults. | approved | Jan 30, 1998 | openfda |
| Gilteritinib | US FDA | — | Efficacy supplement 2019-05-29 (see label) | approved | May 29, 2019 | openfda |
| Gilteritinib | US FDA | Acute Myeloid Leukemia | XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. | approved | Nov 28, 2018 | openfda |
| Midostaurin | US FDA | — | Efficacy supplement 2020-11-24 (see label) | approved | Nov 24, 2020 | openfda |
| Midostaurin | US FDA | Acute Myeloid Leukemia | 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. | approved | Apr 28, 2017 | openfda |
| Midostaurin | US FDA | Acute Myeloid Leukemia | 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. | approved | Apr 28, 2017 | openfda |
| Midostaurin | US FDA | — | 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). | approved | Apr 28, 2017 | openfda |
| Midostaurin | US FDA | — | 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). | approved | Apr 28, 2017 | openfda |
| Ponatinib | US FDA | — | Efficacy supplement 2025-10-10 (see label) | approved | Oct 10, 2025 | openfda |
| Ponatinib | US FDA | — | Efficacy supplement 2024-03-19 (see label) | approved | Mar 19, 2024 | openfda |
| Ponatinib | US FDA | — | Efficacy supplement 2022-02-15 (see label) | approved | Feb 15, 2022 | openfda |
| Ponatinib | US FDA | — | Efficacy supplement 2020-12-18 (see label) | approved | Dec 18, 2020 | openfda |
| Ponatinib | US FDA | — | Efficacy supplement 2016-11-28 (see label) | approved | Nov 28, 2016 | openfda |
| Ponatinib | US FDA | — | Efficacy supplement 2016-06-02 (see label) | approved | Jun 2, 2016 | openfda |
| Ponatinib | US FDA | — | ICLUSIG ® is indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Newly diagnosed Ph+ ALL in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL. Chronic Myeloid Leukemia (CML) Chronic phase (CP) CML with resistance or intolerance to at least two prior kinase inhibitors. Accelerated phase (AP) or blast phase (BP) CML for whom no other kinase inhibitors are indicated. T315I-positive CML (chronic phase, accelerated phase, or blast phase). ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Newly diagnosed Ph+ ALL, in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 ) As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL. ( 1 ) Chronic Myeloid Leukemia (CML) Chronic phase (CP) CML with resistance or intolerance to at least two prior kinase inhibitors. ( 1 ) Accelerated phase (AP) or blast phase (BP) CML for whom no other kinase inhibitors are indicated. ( 1 ) T315I-positive CML (chronic phase, accelerated phase, or blast phase). ( 1 ) Limitations of Use : ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML. ( 5.7 ) Limitations of Use : ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML [see Warnings and Precautions (5.7) ] .accelerated | approved | Dec 14, 2012 | openfda |
| Quizartinib | US FDA | Acute Myeloid Leukemia | VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test [see Dosage and Administration (2.1) and Clinical Studies (14) ] . VANFLYTA is a kinase inhibitor indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test. ( 1 ) Limitations of Use: VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated. ( 1 ) Limitations of Use VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated [see Clinical Studies (14) ] . | approved | Jul 20, 2023 | openfda |
| Selumetinib | US FDA | — | Efficacy supplement 2025-11-19 (see label) | approved | Nov 19, 2025 | openfda |
| Selumetinib | US FDA | — | Efficacy supplement 2025-09-10 (see label) | approved | Sep 10, 2025 | openfda |
| Selumetinib | US FDA | — | KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2) ]. KOSELUGO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). ( 1 ) | approved | Sep 10, 2025 | openfda |
| Selumetinib | US FDA | — | Efficacy supplement 2024-01-24 (see label) | approved | Jan 24, 2024 | openfda |
| Selumetinib | US FDA | — | KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2) ]. KOSELUGO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). ( 1 ) | approved | Apr 10, 2020 | openfda |
| Sorafenib | US FDA | — | Efficacy supplement 2017-12-22 (see label) | approved | Dec 22, 2017 | openfda |
| Sorafenib | US FDA | — | Efficacy supplement 2013-11-22 (see label) | approved | Nov 22, 2013 | openfda |
| Sorafenib | US FDA | — | Efficacy supplement 2007-11-16 (see label) | approved | Nov 16, 2007 | openfda |
| Sorafenib | US FDA | — | Efficacy supplement 2007-11-16 (see label) | approved | Nov 16, 2007 | openfda |
| Sorafenib | US FDA | — | Efficacy supplement 2007-11-16 (see label) | approved | Nov 16, 2007 | openfda |
| Sorafenib | US FDA | — | Efficacy supplement 2007-11-16 (see label) | approved | Nov 16, 2007 | openfda |
| Sorafenib | US FDA | Hepatocellular Carcinoma | NEXAVAR is a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma | approved | Dec 1, 2005 | openfda |
| Sorafenib | US FDA | Renal Cell Carcinoma | Advanced renal cell carcinoma | approved | Dec 1, 2005 | openfda |
| Sorafenib | US FDA | Differentiated Thyroid Gland Carcinoma | Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment | approved | Dec 1, 2005 | openfda |
| Sunitinib | US FDA | — | Efficacy supplement 2021-08-30 (see label) | approved | Aug 30, 2021 | openfda |
| Sunitinib | US FDA | — | Efficacy supplement 2019-05-07 (see label) | approved | May 7, 2019 | openfda |
| Sunitinib | US FDA | — | Efficacy supplement 2017-11-16 (see label) | approved | Nov 16, 2017 | openfda |
| Sunitinib | US FDA | — | Efficacy supplement 2011-05-20 (see label) | approved | May 20, 2011 | openfda |
| Sunitinib | US FDA | — | Efficacy supplement 2010-07-01 (see label) | approved | Jul 1, 2010 | openfda |
| Sunitinib | US FDA | — | Efficacy supplement 2007-02-02 (see label) | approved | Feb 2, 2007 | openfda |
| Sunitinib | US FDA | — | Efficacy supplement 2007-02-02 (see label) | approved | Feb 2, 2007 | openfda |
| Sunitinib | US FDA | — | Efficacy supplement 2007-02-02 (see label) | approved | Feb 2, 2007 | openfda |
| Sunitinib | US FDA | — | treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. • adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy. | approved | Jan 26, 2006 | openfda |
| Sunitinib | US FDA | Renal Cell Carcinoma | treatment of adult patients with advanced renal cell carcinoma (RCC). | approved | Jan 26, 2006 | openfda |
| Sunitinib | US FDA | Primitive Neuroectodermal Tumor | treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease. | approved | Jan 26, 2006 | openfda |
| Tretinoin | US FDA | — | ALTRENO ® (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ALTRENO is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. (1) | approved | Aug 23, 2018 | openfda |
| Tretinoin | US FDA | — | Atralin Gel is indicated for topical treatment of acne vulgaris. Atralin Gel is a retinoid indicated for topical treatment of acne vulgaris. ( 1 ) | approved | Jul 26, 2007 | openfda |
| Tretinoin | US FDA | — | Efficacy supplement 2002-05-10 (see label) | approved | May 10, 2002 | openfda |
| Tretinoin | US FDA | Malignant Skin Neoplasm | Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time. | approved | Aug 31, 2000 | openfda |
| Tretinoin | US FDA | — | (To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. • RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis. • RENOVA (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing. • Neither the safety nor the effectiveness of RENOVA (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established. • Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials (see WARNINGS ). Clinical Trials Four adequate and well-controlled multi-center trials and one single-center randomized, controlled trial were conducted involving a total of 324 evaluable patients treated with RENOVA (tretinoin cream) 0.02% and 332 evaluable patients treated with the vehicle cream on the face for 24 weeks with a comprehensive skin care and sun avoidance program, to assess the effects on fine and coarse wrinkling, mottled hyperpigmentation, tactile skin roughness, and laxity. Patients were evaluated at baseline on a 10-unit scale and changes from that baseline rating were categorized as follows: Worsening: Increase of 1 unit or more. No improvement: No change. Minimal improvement: Reduction of 1 unit. Mild improvement: Reduction of 2 units. Moderate improvement: Reduction of 3 units or more. In these trials, the fine and coarse wrinkling, mottled hyperpigmentation, tactile roughness, and laxity of the facial skin were thought to be caused by multiple factors which included intrinsic aging or environmental factors, such as chronic sunlight exposure. Two of the five trials provided adequate demonstration of efficacy for mitigation of fine facial wrinkling. No two of the five trials adequately demonstrated efficacy for mitigation of coarse wrinkling, mottled hyperpigmentation, tactile skin roughness, and laxity. Data for fine wrinkling (the indication for which RENOVA (tretinoin cream) 0.02% demonstrated efficacy) from all five trials (four studies in lightly pigmented subjects with Fitzpatrick Skin Types I-III and one study in darkly pigmented subjects with Fitzpatrick Skin Types IV-VI) is provided below: FINE WRINKLING IN LIGHTLY PIGMENTED SUBJECTS Subjects Using RENOVA (tretinoin cream) 0.02% + CSP * (N=279) Vehicle + CSP * (N=280) A single-center study (N=107) in darkly pigmented, mostly African-American, subjects with Fitzpatrick Skin Types IV-VI demonstrated minimal or mild improvement in fine facial wrinkling in 43% of patients using Vehicle + CSP* compared to 29% of subjects using RENOVA (tretinoin cream) 0.02% + CSP*. Although fewer darkly pigmented subjects improved with RENOVA (tretinoin cream) 0.02% than with vehicle, these findings ma… |
| Tretinoin | US FDA | — | RETIN-A MICRO ® is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. RETIN-A MICRO is a retinoid indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. ( 1) | approved | Feb 7, 1997 | openfda |
| Tretinoin | US FDA | — | Tretinoin Cream, USP is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of this product in the treatment of other disorders have not been established. | approved | Jan 14, 1997 | openfda |
| Tretinoin | US FDA | — | Tretinoin is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established. | approved | Sep 16, 1988 | openfda |