Skip to Content

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: Contraception

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) for Injection

Date of Approval: December 18, 2019
Company: Astellas and Seattle Genetics
Treatment for: Urothelial Carcinoma

Padcev (enfortumab vedotin-ejfv) is a Nectin-4 targeted 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: Hypertension

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

Enhertu (fam-trastuzumab deruxtecan-nxki) is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

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

Caplyta (lumateperone) is an atypical antipsychotic for the treatment of schizophrenia.

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.

New Drug Approvals Archive

More News Resources

Subscribe to our Newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.