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New Drug Approvals Archive - November 2019

See also: New Indications and Dosage Forms for November 2019

November 2019

Talicia (amoxicillin, omeprazole and rifabutin) Delayed-Release Capsules

Date of Approval: November 4, 2019
Company: RedHill Biopharma Ltd.
Treatment for: Helicobacter pylori Infection

Talicia (omeprazole magnesium, amoxicillin and rifabutin) is a fixed-dose combination of two antibiotics, (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole) for the treatment of Helicobacter pylori (H. pylori) infection.

Ziextenzo (pegfilgrastim-bmez) Injection

Date of Approval: November 4, 2019
Company: Sandoz
Treatment for: Neutropenia Associated with Chemotherapy

Ziextenzo (pegfilgrastim-bmez) is a PEGylated growth colony-stimulating factor biosimilar to Neulasta (pegfilgrastim) used to reduce the incidence of febrile neutropenia in patients treated with chemotherapy.

Reblozyl (luspatercept-aamt) for Injection

Date of Approval: November 8, 2019
Company: Celgene Corporation
Treatment for: Anemia in Beta-Thalassemia; Anemia in Lower-Risk Myelodysplastic Syndromes

Reblozyl (luspatercept-aamt) is a first-in-class erythroid maturation agent (EMA) for the treatment of:

  • Anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
  • Anemia failing an erythropoiesis stimulating agent and requiring 2 or more RBC units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
  • Limitations of Use: Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

Brukinsa (zanubrutinib) Capsules

Date of Approval: November 14, 2019
Company: BeiGene, Ltd.
Treatment for: Mantle Cell Lymphoma

Brukinsa (zanubrutinib) is a Bruton’s tyrosine kinase (BTK) inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Fetroja (cefiderocol) Injection

Date of Approval: November 14, 2019
Company: Shionogi & Co., Ltd.
Treatment for: Complicated Urinary Tract Infections

Fetroja (cefiderocol) is a siderophore cephalosporin indicated for the treatment of complicated urinary tract infections (cUTI) in patients with limited or no alternative treatment options.

Adakveo (crizanlizumab-tmca) Injection

Date of Approval: November 15, 2019
Company: Novartis
Treatment for: Prevention of Vaso-Occlusive Crises (VOCs) in Sickle Cell Disease

Adakveo (crizanlizumab-tmca) is a P-selectin inhibitor for the prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD).

Abrilada (adalimumab-afzb) Injection

Date of Approval: November 15, 2019
Company: Pfizer Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease -- Maintenance, Ulcerative Colitis, Plaque Psoriasis

Abrilada (adalimumab-afzb) is a tumor necrosis factor (TNF) blocker biosimilar to Humira indicated for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), and plaque psoriasis (Ps).

Givlaari (givosiran) Injection

Date of Approval: November 20, 2019
Company: Alnylam Pharmaceuticals, Inc.
Treatment for: Acute Hepatic Porphyria

Givlaari (givosiran) is an aminolevulinate synthase 1-directed small interfering RNA (siRNA) indicated for the treatment of adults with acute hepatic porphyria (AHP).

Xcopri (cenobamate) Tablets

Date of Approval: November 21, 2019
Company: SK Life Science, Inc.
Treatment for: Seizures

Xcopri (cenobamate) is an antiepileptic drug for the treatment of partial-onset seizures in adult patients.

Exservan (riluzole) Oral Film

Date of Approval: November 22, 2019
Company: Aquestive Therapeutics, Inc.
Treatment for: Amyotrophic Lateral Sclerosis

Exservan (riluzole) an oral film formulation of the approved glutamate Inhibitor riluzole for the treatment of patients with amyotrophic lateral sclerosis (ALS) patients who have difficulty swallowing.

Oxbryta (voxelotor) Tablets

Date of Approval: November 25, 2019
Company: Global Blood Therapeutics, Inc.
Treatment for: Sickle Cell Anemia

Oxbryta (voxelotor) is an oral, HbS (sickle hemoglobin) polymerization inhibitor for the treatment of patients with sickle cell disease (SCD).

RediTrex (methotrexate) Injection

Date of Approval: November 27, 2019
Company: Cumberland Pharmaceuticals Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriasis

RediTrex (methotrexate) is a folate analog metabolic inhibitor indicated for the management of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), and psoriasis.

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