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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 and Dosage forms

    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.

    Detectnet (copper Cu 64 dotatate) Injection

    Company: RadioMedix Inc.
    Date of Approval: September 3, 2020
    Treatment for: Positron Emission Tomography Imaging

    Detectnet (copper Cu 64 dotatate) is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.

    Onureg (azacitidine) Tablets

    Company: Bristol-Myers Squibb Company
    Date of Approval: September 1, 2020
    Treatment for: Acute Myeloid Leukemia

    Onureg (azacitidine) is a nucleoside metabolic inhibitor indicated for the continued treatment of adult patients with acute myeloid leukemia.

    Qdolo (tramadol hydrochloride) Oral Solution

    Company: Athena Bioscience, LLC
    Date of Approval: September 1, 2020
    Treatment for: Pain

    Qdolo (tramadol hydrochloride) is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

    Xaracoll (bupivacaine hydrochloride) Implant

    Company: Innocoll Holdings Limited
    Date of Approval: August 28, 2020
    Treatment for: Postsurgical Pain Relief Following Open Inguinal Hernia

    Xaracoll (bupivacaine hydrochloride) is a fully bioresorbable collagen implant containing the local anesthetic bupivacaine indicated for acute postsurgical pain relief for up to 24 hours in adults following open inguinal hernia repair.

    Sogroya (somapacitan-beco) Injection

    Company: Novo Nordisk
    Date of Approval: August 28, 2020
    Treatment for: Adult Human Growth Hormone Deficiency

    Sogroya (somapacitan-beco) is a human growth hormone analog indicated for the replacement of endogenous growth hormone in adults with growth hormone deficiency.

    Winlevi (clascoterone) Cream

    Company: Cassiopea SpA
    Date of Approval: August 26, 2020
    Treatment for: Acne

    Winlevi (clascoterone) cream is a first-in-class topical androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

    Kesimpta (ofatumumab) Injection

    Company: Novartis Pharmaceuticals Corporation
    Date of Approval: August 20, 2020
    Treatment for: Multiple Sclerosis

    Kesimpta (ofatumumab) is a CD20-directed cytolytic antibody indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

    Cystadrops (cysteamine hydrochloride) Ophthalmic Solution

    Company: Recordati Rare Diseases Inc.
    Date of Approval: August 19, 2020
    Treatment for: Corneal Cystine Crystal Accumulation

    Cystadrops (cysteamine hydrochloride) is a cystine-depleting agent indicated for the treatment of corneal cystine crystal deposits in adults and children with cystinosis.

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    FDA Drug Approvals Archive

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