New Drug Approvals Archive - December 2019
See also: New Indications and Dosage Forms for December 2019
December 2019
Avsola (infliximab-axxq) Injection
Date of Approval: December 6, 2019
Company: Amgen Inc.
Treatment for: Crohn's Disease, Maintenance, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis, Plaque Psoriasis
Avsola (infliximab-axxq) is a tumor necrosis factor (TNF) blocker biosimilar to Remicade indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
Vyondys 53 (golodirsen) Injection
Date of Approval: December 12, 2019
Company: Sarepta Therapeutics, Inc.
Treatment for: Duchenne Muscular Dystrophy
Vyondys 53 (golodirsen) is a phosphordiamidate morpholino oligimer for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping.
EluRyng (ethinyl estradiol and etonogestrel) Vaginal Ring
Date of Approval: December 11, 2019
Company: Amneal Pharmaceuticals, Inc.
Treatment for: Birth Control
EluRyng (ethinyl estradiol/etonogestrel vaginal ring) is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy.
EluRyng is the first approved generic version of NuvaRing.
Nouress (cysteine hydrochloride) Injection
Date of Approval: December 13, 2019
Company: Avadel Pharmaceuticals plc
Treatment for: Total Parenteral Nutrition
Nouress (cysteine hydrochloride) is a sulfur-containing amino acid indicated for use as an additive to amino acid solutions to meet nutritional requirements of neonates requiring total parenteral nutrition.
Padcev (enfortumab vedotin-ejfv) Lyophilized Powder for Injection
Date of Approval: December 18, 2019
Company: Astellas
Treatment for: Urothelial Carcinoma
Padcev (enfortumab vedotin-ejfv) is a Nectin-4 directed antibody-drug conjugate (ADC) for the treatment of patients with locally advanced or metastatic urothelial cancer.
Arazlo (tazarotene) Lotion
Date of Approval: December 18, 2019
Company: Bausch Health Companies Inc.
Treatment for: Acne
Arazlo (tazarotene) is a lotion formulation of the approved retinoid tazarotene for the topical treatment of acne vulgaris in patients 9 years of age and older.
Ervebo (ebola zaire vaccine, live) Injection - formerly V920
Date of Approval: December 19, 2019
Company: Merck
Treatment for: Prevention of Ebola Zaire Disease
Ervebo (ebola zaire vaccine, live) is a vaccine indicated for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older.
Conjupri (levamlodipine maleate) Tablets
Date of Approval: December 19, 2019
Company: CSPC Pharmaceutical Group Limited
Treatment for: High Blood Pressure
Conjupri (levamlodipine maleate) is a calcium channel blocker indicated for the treatment of hypertension.
Enhertu (fam-trastuzumab deruxtecan-nxki) Injection
Date of Approval: December 20, 2019
Company: AstraZeneca and Daiichi Sankyo Company, Limited
Treatment for: Breast Cancer, Gastric Cancer
Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody and topoisomerase inhibitor conjugate used for the treatment of HER2-positive breast cancer and HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Ubrelvy (ubrogepant) Tablets
Date of Approval: December 23, 2019
Company: Allergan plc
Treatment for: Migraine
Ubrelvy (ubrogepant) is a potent, orally-administered CGRP receptor antagonist for the acute treatment of migraine with or without aura in adults.
Caplyta (lumateperone) Capsules
Date of Approval: December 20, 2019
Company: Intra-Cellular Therapies, Inc.
Treatment for: Schizophrenia, Bipolar Disorder
Caplyta (lumateperone) is an atypical antipsychotic for the treatment of schizophrenia and bipolar depression.
Dayvigo (lemborexant) Tablets
Date of Approval: December 20, 2019
Company: Eisai Co., Ltd.
Treatment for: Insomnia
Dayvigo (lemborexant) is dual orexin receptor antagonist (DORA) for the treatment of insomnia.
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