2022
Therapy Area: Antifungal | FDA
REZZAYO™
REZZAYO (rezafungin) is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis.
Therapy Area: Neurodegenerative Disease | FDA
RELYVRIO®
RELYVRIO (sodium phenylbutyrate and taurursodiol) is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.
Therapy Area: Dermatology | FDA
SPEVIGO®
SPEVIGO (spesolimab-sbzo) is an interleukin-36 receptor antagonist indicated for the treatment of generalized pustular psoriasis flares in adults.
Therapy Area: Rare Disease | FDA
AMVUTTRA™
AMVUTTRA (vutrisiran) injection is a transthyretin-directed small interfering RNA indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Therapy Area: Blood Disorders | FDA
PYRUKYND®
PYRUKYND (mitapivat) is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.
2021
Therapy Area: Oncology | FDA
CAMCEVI®
CAMCEVI (leuprolide) 42 mg subcutaneous injection is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer. CAMCEVI is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or the components of CAMCEVI.
2020
Therapy Area: Oncology | FDA
CABOMETYX®
CABOMETYX (cabozantinib) is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC) and patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Therapy Area: Prostate Cancer | FDA
ORGOVYX™
ORGOVYX (relugolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.
Therapy Area: Urinary | FDA
GEMTESA®
GEMTESA (vibegron) is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
Therapy Area: Rare Disease | EMA
OXLUMO™
OXLUMO (lumasiran) is an RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.
Therapy Area: Antiviral | FDA
VEKLURY®
VEKLURY (remdesivir) is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization. VEKLURY should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.
Therapy Area: Rare Disease | FDA
ONUREG®
ONUREG (azacitidine) is a nucleoside metabolic inhibitor indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.
Therapy Area: Rare Disease | FDA
GIVLAARI®
GIVLAARI (givosiran) is an aminolevulinate synthase 1-directed small interfering RNA indicated for the treatment of adults with acute hepatic porphyria.
Therapy Area: Rare Disease | FDA
TEGSEDI®
TEGSEDI (inotersen) is a transthyretin-directed antisense oligonucleotide indicated for treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
Therapy Area: Rare Disease | EMA Conditional Approval
WAYLIVRA®
WAYLIVRA (volanesorsen) is indicated as an adjunct to diet in adult patients with genetically confirmed familial chylomicronemia syndrome (FCS) and at high risk for pancreatitis, in whom response to diet and triglyceride lowering therapy has been inadequate.
Therapy Area: Oncology | FDA
INQOVI®
INQOVI (decitabine and cedazuridine tablet) is a combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor, indicated for treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following FrenchAmerican-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
Therapy Area: Oncology | FDA
POMALYST®
POMALYST (pomalidomide), which was granted priority review designation and breakthrough therapy designation by the FDA, received an expanded indication to include treating adult patients with AIDS-related Kaposi Sarcoma after failure of highly active antiretroviral therapy and Kaposi Sarcoma in adult patients who are HIV-negative.
Therapy Area: Oncology | FDA
TRIFERIC®
TRIFERIC (ferric pyrophosphate citrate) is an iron replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).
2019
Therapy Area: Oncology | FDA
Ruxience®
RUXIENCE (rituximab-pvvr) is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with: Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids.
Therapy Area: Oncology | FDA
ZIRABEV®
ZIRABEV™ (bevacizumab-bvzr), a biosimilar to Avastin® (bevacizumab),1 for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer.
2018
Therapy Area: Neurology | FDA
FIRDAPSE®
“FIRDAPSE is a potassiumchannel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.”
Therapy Area: Rare Disease | FDA
HEMLIBRA®
HEMLIBRA is a bispecific factor IXa- and factor X-directed antibody indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.
Therapy Area: Rare Disease | FDA
ONPATTRO®
Onpattro (patisiran) – ONPATTRO is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults
2017
Therapy Area: Oncology | FDA
BAVENCIO®
“BAVENCIO (avelumab) is indicated for the treatment of: Adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC) Patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy”
2016
Therapy Area: Infectious Disease | FDA
VEMLIDY®
VEMLIDY is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease
Therapy Area: Infectious Disease | FDA
EPCLUSA®
“EPCLUSA is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, and is indicated for the treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection:
- without cirrhosis or with compensated cirrhosis
- with decompensated cirrhosis for use in combination with ribavirin”
Therapy Area: Vaccines | FDA
ANTHIM®
ANTHIM® is a monoclonal antibody directed against the protective antigen of Bacillus anthracis. It is indicated in adult and pediatric patients for treatment of inhalational anthrax due to B. anthracis in combination with appropriate antibacterial drugs and, for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.
Therapy Area: Oncology | FDA
REVLIMID®
“REVLIMID is a thalidomide analogue indicated for the treatment of patients with:
- Multiple myeloma (MM), in combination with dexamethasone.
- MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).
- Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
- Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.”
Therapy Area: Respiratory | FDA
CINQAIR®
CINQAIR is an interleukin-5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype
Therapy Area: Oncology | FDA
SUSTOL®
“SUSTOL is a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens.”
2014
Therapy Area: Infectious Disease | FDA
HARVONI®
HARVONI is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults.
Therapy Area: Inflammation | FDA
ENTYVIO®
“ENTYVIO is an integrin receptor antagonist indicated for:
- Adult Ulcerative Colitis (UC)
- Adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids.
- Adult Crohn’s Disease (CD)
- Adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids.”
Therapy Area: Endocrinology | FDA
AFREZZA®
AFREZZA® is a rapid acting inhaled insulin indicated to improve glycemic control in adult patients with diabetes mellitus.
Therapy Area: Endocrinology | FDA
TANZEUM®
“TANZEUM is a GLP-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.”
2013
Therapy Area: Women’s Health | FDA
OSPHENA®
OSPHENA is an estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
Therapy Area: Neurology | FDA
HETLIOZ®
HETLIOZ is a melatonin receptor agonist indicated for the treatment of Non24-Hour Sleep-Wake Disorder (Non-24).
Therapy Area: Oncology | FDA
KADCYLA®
KADCYLA is a HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.
Therapy Area: Infectious Disease | FDA
SOVALDI®
“SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. “
2012
Therapy Area: Oncology | FDA
COMETRIQ®
COMETRIQ is a kinase inhibitor indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC).
Therapy Area: Oncology | FDA
ERIVEDGE®
“ERIVEDGE™ (vismodegib) capsule is a hedgehog pathway inhibitor indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.”
Therapy Area: Infectious Disease | FDA
SIRTURO®
SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adults (≥ 18 years) with pulmonary multi-drug resistant tuberculosis (MDR-TB).
2011
Therapy Area: Pain | FDA
EXPAREL®
EXPAREL is a liposome injection of bupivacaine, an amide-type local anesthetic, indicated for administration into the surgical site to produce postsurgical analgesia.
Therapy Area: Women’s Health | FDA
PROLIA®
Prolia is a RANK ligand (RANKL) inhibitor indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
Therapy Area: Infectious Disease | FDA
INCIVEK®
INCIVEK is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated, in combination with peginterferon alfa and ribavirin, for the treatment of genotype 1 chronic hepatitis C (CHC) in adult patients with compensated liver disease, including cirrhosis, who are treatment-naïve or who have been previously treated with interferon-based treatment, including prior null responders, partial responders, and relapsers.
2010
Therapy Area: Oncology | FDA
ISTODAX®
ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.
Therapy Area: Women’s Health | FDA
BEYAZ®
Beyaz is an estrogen/progestin COC containing a folate, indicated for use by women to: prevent pregnancy, treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception, treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control, raise folate levels in women who choose to use an oral contraceptive for contraception.
Therapy Area: Neurology | FDA
GILENYA®
GILENYA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
Therapy Area: Inflammation | Ruconest.com
RUCONEST®
RUCONEST is an injectable medicine that is used to treat acute angioedema attacks in adult and adolescent patients with Hereditary Angioedema (HAE)
Therapy Area: Inflammation | FDA
ACTEMRA®
“ACTEMRA® (tocilizumab) is an interleukin-6 (IL-6) receptor inhibitor indicated for treatment of adult patients with moderately-to severely- active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.”
2009
Therapy Area: Neurology | FDA
SAPHRIS®
“SAPHRIS is an atypical antipsychotic indicated for:
-
- Acute treatment of schizophrenia in adults
Acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.”
Therapy Area: Oncology | EMA Approved Only
JAVLOR®
Javlor is indicated in monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen.
2008
Therapy Area: Neurology | FDA
BRIDION®
BRIDION is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery
2007
Therapy Area: Endocrinology | FDA
WELCHOL®
WELCHOL, administered alone or in combination with an HMG-CoA reductase inhibitor, is indicated as adjunctive therapy to diet and exercise for the reduction of elevated LDL cholesterol in patients with primary hypercholesterolemia (Fredrickson Type 2a)
Therapy Area: Infectious Disease | FDA
ISENTRESS®
ISENTRESS™ is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.
2006
Therapy Area: Antifungal | FDA
NOXAFIL®
NOXAFIL (posaconazole) is indicated for prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with Graft versus Host Disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
2004
Therapy Area: Oncology | FDA
AVASTIN®
AVASTIN, used in combination with intravenous 5-fluorouracil–based chemotherapy, is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum.
2002
Therapy Area: Infectious Disease | FDA
PEGASYS®
PEGASYS, peginterferon alfa-2a, is indicated for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not been previously treated with interferon alfa. Patients in whom efficacy was demonstrated included patients with compensated cirrhosis.
2001
Therapy Area: Women’s Health | FDA
NUVARING®
NuvaRing is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.
1999
Therapy Area: Neurology | FDA
KEPPRA®
Keppra (levetiracetam) is indicated as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy.
1997
Therapy Area: Oncology | FDA
RITUXAN®
RITUXAN is indicated for the Vealmem of patients with relapsed or refractory low-grade or follicular. CD20 positive. B-cell non-Hodgkin’s lymphoma
1987
Therapy Area: Women’s Health | FDA
LIVIAL®
“Therapeutic indications:
- Treatment of oestrogen deficiency symptoms in postmenopausal women, more than one year after menopause.
- Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.”
