New Drugs Approval
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1) Zeposia (ozanimod) Capsules
Company: Bristol-Myers Squibb Company
Date of Approval: March 25, 2020
Treatment for: Multiple Sclerosis
Zeposia (ozanimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS).
2) Isturisa (osilodrostat) Tablets
Company: Novartis Pharmaceuticals Corporation
Date of Approval: March 6, 2020
Treatment for: Cushing's Syndrome
Isturisa (osilodrostat) is a cortisol synthesis inhibitor indicated for the treatment of adult patients with Cushing’s disease.
3) Durysta (bimatoprost) Implant
Company: Allergan plc
Date of Approval: March 3, 2020
Treatment for: Glaucoma (Open Angle), Intraocular Hypertension
Durysta (bimatoprost implant) is a prostaglandin analog indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).
5) Advil Dual Action (ibuprofen and acetaminophen) Tablets
Company: GlaxoSmithKline Consumer Healthcare LP
Date of Approval: February 28, 2020
Treatment for: Pain
Advil Dual Action (ibuprofen with acetaminophen) is an over-the-counter (OTC) fixed-dose combination of ibuprofen (the nonsteroidal anti-inflammatory drug (NSAID) contained in Advil) and acetaminophen (the active ingredient in Tylenol) for the relief of pain.
6) Nurtec ODT (rimegepant) Orally Disintegrating Tablets
Company: Biohaven Pharmaceutical Holding Company Ltd.
Date of Approval: February 27, 2020
Treatment for: Migraine
Nurtec ODT (rimegepant) is an orally-dosed calcitonin gene-related peptide (CGRP) receptor antagonist for the acute treatment of migraine.
7) Nexlizet (bempedoic acid and ezetimibe) Tablets
Company: Esperion Therapeutics
Date of Approval: February 26, 2020
Treatment for: Heterozygous Familial Hypercholesterolemia
Nexlizet (bempedoic acid and ezetimibe) is an adenosine triphosphate-citrate lyase (ACL) inhibitor and a cholesterol absorption inhibitor combination indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.
8) Barhemsys (amisulpride) Injection
Company: Acacia Pharma
Date of Approval: February 26, 2020
Treatment for: Nausea/Vomiting -- Postoperative
Barhemsys (amisulpride) is a dopamine antagonist for the management of post-operative nausea & vomiting (PONV).
9) Nexletol (bempedoic acid) Tablets
Company: Esperion Therapeutics, Inc.
Date of Approval: February 21, 2020
Treatment for: Heterozygous Familial Hypercholesterolemia
Nexletol (bempedoic acid) is a first-in-class, adenosine triphosphate-citrate lyase (ACL) inhibitor for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-Cholesterol.
10) Vyepti (eptinezumab-jjmr) Injection
Company: Lundbeck Inc.
Date of Approval: February 21, 2020
Treatment for: Migraine Prophylaxis
Vyepti (eptinezumab-jjmr) is a calcitonin gene-related peptide antagonist indicated for the prevention of migraine in adults.
11) Anjeso (meloxicam) Injection
Company: Baudax Bio, Inc.
Date of Approval: February 20, 2020
Treatment for: Pain
Anjeso (meloxicam) is a non-steroidal anti-inflammatory drug (NSAID) injection indicated for use in adults for the management of moderate-to-severe pain, alone or in combination with non-NSAID analgesics
Media Contact:
Allison Grey
Journal Manager
Journal of Clinical chemistry and Laboratory Medicne
Email: jcclm@molecularbiol.com