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