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New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic approvals, Approval process, New indications & dosage forms

Gemtesa (vibegron) Tablets

Company: Urovant Sciences
Date of Approval: December 23, 2020
Treatment for: Overactive Bladder Syndrome

Gemtesa (vibegron) is a once-daily beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

Ebanga (ansuvimab-zykl) Injection

Company: Ridgeback Biotherapeutics, LP.
Date of Approval: December 21, 2020
Treatment for: Zaire Ebolavirus Infection

Ebanga (ansuvimab-zykl) is a monoclonal antibody for the treatment of Zaire ebolavirus (Ebolavirus) infection in adults and children.

Orgovyx (relugolix) Tablets

Company: Myovant Sciences
Date of Approval: December 18, 2020
Treatment for: Prostate Cancer

Orgovyx (relugolix) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.

Riabni (rituximab-arrx) Injection

Company: Amgen Inc.
Date of Approval: December 17, 2020
Treatment for: non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Wegener's Granulomatosis, Microscopic Polyangiitis

Riabni (rituximab-arrx) is a CD20-directed cytolytic antibody biosimilar to Rituxan indicated for the treatment of adult patients with non-Hodgkin’s Lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyangiitis (MPA).

Margenza (margetuximab-cmkb) Injection

Company: MacroGenics, Inc.
Date of Approval: December 16, 2020
Treatment for: Breast Cancer

Margenza (margetuximab-cmkb) is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2- positive breast cancer.

Klisyri (tirbanibulin) Ointment

Company: Athenex, Inc.
Date of Approval: December 14, 2020
Treatment for: Actinic Keratosis

Klisyri (tirbanibulin) is a first-in-class dual Src Kinase and tubulin polymerization inhibitor for the topical treatment of actinic keratosis on the face or scalp.

Orladeyo (berotralstat) Capsules

Company: BioCryst Pharmaceuticals, Inc.
Date of Approval: December 3, 2020
Treatment for: Hereditary Angioedema

Orladeyo (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.

Ga 68 PSMA-11 Injection

Company: University of California, San Francisco
Date of Approval: December 1, 2020
Treatment for: Diagnostic

Ga 68 PSMA-11 Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

Danyelza (naxitamab-gqgk) Injection

Company: Y-mAbs Therapeutics, Inc.
Date of Approval: November 25, 2020
Treatment for: Neuroblastoma

Danyelza (naxitamab-gqgk) is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GMCSF), for the treatment of patients with relapsed or refractory high-risk neuroblastoma.

Imcivree (setmelanotide) Injection

Company: Rhythm Pharmaceuticals, Inc.
Date of Approval: November 25, 2020
Treatment for: Obesity

Imcivree (setmelanotide) is a melanocortin 4 (MC4) receptor agonist for chronic weight management of obesity due to proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency.

Oxlumo (lumasiran) Injection

Company: Alnylam Pharmaceuticals, Inc.
Date of Approval: November 23, 2020
Treatment for: Primary Hyperoxaluria Type 1 (PH1)

Oxlumo (lumasiran) is a HAO1-directed small interfering ribonucleic acid (siRNA) indicated for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patients.

Zokinvy (lonafarnib) Capsules

Company: Eiger BioPharmaceuticals, Inc.
Date of Approval: November 20, 2020
Treatment for: Progeria and Progeroid Laminopathies

Zokinvy (lonafarnib) is an oral farnesyltransferase inhibitor (FTI) for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies (PL).

Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets

Company: Sebela Pharmaceuticals, Inc.
Date of Approval: November 10, 2020
Treatment for: Bowel Preparation

Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) is an osmotic laxative in a tablet formulation indicated for cleansing the colon in preparation for colonoscopy in adults.

Sesquient (fosphenytoin sodium) for Injection

Company: Sedor Pharmaceuticals, LLC
Date of Approval: November 5, 2020
Treatment for: Status Epilepticus

Sesquient (fosphenytoin sodium for injection) is a Captisol-enabled™, room-temperature stable formulation of fosphenytoin sodium indicated for the treatment of status epilepticus in adults and children.

Bronchitol (mannitol) Inhalation Powder

Company: Chiesi USA, Inc.
Date of Approval: October 30, 2020
Treatment for: Cystic Fibrosis

Bronchitol (mannitol) is an inhaled dry powder formulation of the sugar alcohol mannitol indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years of age and older with cystic fibrosis.

Eysuvis (loteprednol etabonate) Ophthalmic Suspension

Company: Kala Pharmaceuticals, Inc.
Date of Approval: October 26, 2020
Treatment for: Dry Eye Disease

Eysuvis (loteprednol etabonate) is an ophthalmic corticosteroid formulation for the temporary relief of signs and symptoms of dry eye disease.

Veklury (remdesivir) Injection

Company: Gilead Sciences, Inc.
Date of Approval: October 22, 2020
Treatment for: COVID-19

Veklury (remdesivir) is a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for the treatment of COVID-19 patients who require hospitalization.

Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) Injection

Company: Regeneron Pharmaceuticals, Inc.
Date of Approval: October 14, 2020
Treatment for: Zaire Ebolavirus Infection

Inmazeb is (atoltivimab, maftivimab, and odesivimab) is a monoclonal antibody combination indicated for the treatment of Zaire ebolavirus infection in adults and children, including newborns of mothers who have tested positive for the virus.

Alkindi Sprinkle (hydrocortisone) Oral Granules

Company: Eton Pharmaceuticals, Inc.
Date of Approval: September 29, 2020
Treatment for: Adrenocortical Insufficiency

Alkindi Sprinkle (hydrocortisone granules in capsules for opening) is an immediate-release pediatric formulation of the approved glucocorticoid hydrocortisone for the treatment of adrenocortical insufficiency in infants, children and adolescents.

Gavreto (pralsetinib) Capsules

Company: Genentech, Inc.
Date of Approval: September 4, 2020
Treatment for: Non-Small Cell Lung Cancer

Gavreto (pralsetinib) is an oral selective RET kinase inhibitor for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion- positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

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