New Drug Approvals Archive - 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.

• FDA Approves Avsola (infliximab-axxq), a Biosimilar to Remicade
• Avsola (infliximab-axxq) FDA Approval History

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.

• FDA Approves Vyondys 53 (golodirsen) Injection for the Treatment of Duchenne Muscular Dystrophy (DMD) in Patients Amenable to Skipping Exon 53
• Vyondys 53 (golodirsen) FDA Approval History

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.

• FDA Approves EluRyng (etonogestrel/ethinyl estradiol vaginal ring), the First Generic NuvaRing
• EluRyng (ethinyl estradiol and etonogestrel) FDA Approval History

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.

• FDA Approves Nouress (cysteine hydrochloride) Injection for Treating Neonate Patients Requiring Total Parenteral Nutrition (TPN)
• Nouress (cysteine hydrochloride) FDA Approval History

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.

• FDA Approves Padcev (enfortumab vedotin-ejfv) for Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer
• Padcev (enfortumab vedotin-ejfv) FDA Approval History

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.

• FDA Approves Arazlo (tazarotene) Lotion for the Topical Treatment of Acne Vulgaris
• Arazlo (tazarotene) FDA Approval History

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.

• FDA Approves Ervebo (Ebola Zaire Vaccine, Live) for the Prevention of Disease Caused by Zaire Ebolavirus
• Ervebo (ebola zaire vaccine, live) FDA Approval History

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.

• FDA Approves Conjupri (levamlodipine maleate) for the Treatment of Hypertension
• Conjupri (levamlodipine maleate) FDA Approval History

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 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; and adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.

• FDA Approves Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2 Based Regimens
• Enhertu (fam-trastuzumab deruxtecan-nxki) FDA Approval History

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.

• FDA Approves Ubrelvy (ubrogepant) for the Acute Treatment of Migraine
• Ubrelvy (ubrogepant) FDA Approval History

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.

• FDA Approves Caplyta (lumateperone) for the Treatment of Schizophrenia in Adults
• Caplyta (lumateperone) FDA Approval History

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.

• FDA Approves Dayvigo (lemborexant) for the Treatment of Insomnia in Adult Patients
• Dayvigo (lemborexant) FDA Approval History