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New Drug Approvals Archive - November 2020

See also: New Indications and Dosage Forms for November 2020

November 2020

Sesquient (fosphenytoin sodium) for Injection

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

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

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

Date of Approval: November 10, 2020
Company: Sebela Pharmaceuticals, Inc.
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.

Zokinvy (lonafarnib) Capsules

Date of Approval: November 20, 2020
Company: Eiger BioPharmaceuticals, Inc.
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).

Oxlumo (lumasiran)

Date of Approval: November 23, 2020
Company: Alnylam Pharmaceuticals, Inc.
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.

Danyelza (naxitamab-gqgk) Injection

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

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

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