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New Drug Approvals

The following drugs have recently been approved by the FDA. Includes newly approved drugs and new indications for drugs already approved.

See also: Generic Approvals, Approval Process, New Indications and Dosage forms

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).

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.

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).

Sarclisa (isatuximab-irfc) Injection

Company: Sanofi
Date of Approval: March 2, 2020
Treatment for: Multiple Myeloma

Sarclisa (isatuximab-irfc) is a CD38-directed cytolytic antibody indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients multiple myeloma.

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.

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.

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.

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).

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.

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.

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.

Twirla (ethinyl estradiol and levonorgestrel) Transdermal System

Company: Agile Therapeutics, Inc.
Date of Approval: February 14, 2020
Treatment for: Contraception

Twirla (ethinyl estradiol and levonorgestrel transdermal system) is a low-dose combined hormonal contraceptive patch for birth control.

Pemfexy (pemetrexed) Injection

Company: Eagle Pharmaceuticals, Inc.
Date of Approval: February 8, 2020
Treatment for: Non-Small Cell Lung Cancer, Malignant Pleural Mesothelioma

Pemfexy (pemetrexed for injection) is a branded alternative to Alimta for the treatment of nonsquamous non-small cell lung cancer and malignant pleural mesothelioma.

Audenz (influenza A (H5N1) monovalent vaccine, adjuvanted) Injection

Company: Seqirus
Date of Approval: January 31, 2020
Treatment for: Influenza Prophylaxis

Audenz (influenza A (H5N1) monovalent vaccine, adjuvanted) is a cell-based influenza vaccine designed to protect against influenza A (H5N1) in the event of a pandemic.

Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp) - formerly AR101

Company: Aimmune Therapeutics, Inc.
Date of Approval: January 31, 2020
Treatment for: Peanut Allergy

Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp) is an oral immunotherapy indicated to help reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut.

Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Extended-Release Tablets

Company: Boehringer Ingelheim and Eli Lilly and Company
Date of Approval: January 27, 2020
Treatment for: Diabetes Type 2

Trijardy XR (empagliflozin/linagliptin/metformin hydrochloride) is a fixed-dose combination of the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin (Jardiance), the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin (Tradjenta) and the biguanide metformin hydrochloride indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Tazverik (tazemetostat) Tablets

Company: Epizyme, Inc.
Date of Approval: January 23, 2020
Treatment for: Epithelioid Sarcoma

Tazverik (tazemetostat) is a methyltransferase inhibitor for the treatment of patients with epithelioid sarcoma.

Tepezza (teprotumumab-trbw) Injection

Company: Horizon Therapeutics plc
Date of Approval: January 21, 2020
Treatment for: Thyroid Eye Disease

Tepezza (teprotumumab-trbw) is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor 1 receptor (IGF-1R) for the treatment of active thyroid eye disease (TED).

Monoferric (ferric derisomaltose) Injection

Company: Pharmacosmos Therapeutics Inc.
Date of Approval: January 16, 2020
Treatment for: Iron Deficiency Anemia

Monoferric (ferric derisomaltose) is an intravenous iron replacement product indicated for the treatment of iron deficiency anemia.

Numbrino (cocaine hydrochloride) Nasal Solution

Company: Lannett Company, Inc.
Date of Approval: January 10, 2020
Treatment for: Nasal Anesthesia

Numbrino (cocaine hydrochloride) nasal solution is a local anesthetic indicated for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults.

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