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New Drug Approvals Archive - July 2020

See also: New Indications and Dosage Forms for July 2020

July 2020

Byfavo (remimazolam) Injection

Date of Approval: July 2, 2020
Company: Cosmo Pharmaceuticals NV
Treatment for: Sedation

Byfavo (remimazolam) is an ultra-short-acting, intravenous benzodiazepine sedative/anesthetic for the induction and maintenance of procedural sedation in adults.

Rukobia (fostemsavir) Extended-Release Tablets

Date of Approval: July 2, 2020
Company: ViiV Healthcare
Treatment for: HIV Infection

Rukobia (fostemsavir) is a first-in-class, human immunodeficiency virus type 1 (HIV-1) gp120-directed attachment inhibitor indicated for use in combination with other antiretroviral(s) for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection.

Qwo (collagenase clostridium histolyticum-aaes) for Injection

Date of Approval: July 6, 2020
Company: Endo International plc
Treatment for: Cellulite

Qwo (collagenase clostridium histolyticum-aaes) is a combination of bacterial collagenases indicated for the treatment of moderate to severe cellulite in the buttocks of adult women.

Inqovi (decitabine and cedazuridine) Tablets

Date of Approval: July 7, 2020
Company: Astex Pharmaceuticals, Taiho Oncology, and Otsuka Pharmaceutical
Treatment for: Myelodysplastic Syndrome

Inqovi (decitabine and cedazuridine) is a nucleoside metabolic inhibitor and cytidine deaminase inhibitor combination indicated for the treatment of adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML).

Hulio (adalimumab-fkjp) Injection

Date of Approval: July 6, 2020
Company: Mylan Pharmaceuticals Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease -- Maintenance, Ulcerative Colitis, Plaque Psoriasis

Hulio (adalimumab-fkjp) is a tumor necrosis factor (TNF) blocker biosimilar to Humira indicated for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), and plaque psoriasis (Ps).

Upneeq (oxymetazoline hydrochloride) Ophthalmic Solution

Date of Approval: July 8, 2020
Company: Osmotica Pharmaceuticals plc
Treatment for: Blepharoptosis

Upneeq (oxymetazoline hydrochloride ophthalmic solution, 0.1%) is a once-daily ophthalmic formulation of the direct-acting alpha-adrenergic receptor agonist oxymetazoline indicated for the treatment of acquired blepharoptosis, or ptosis, a condition characterized by the abnormal drooping of the upper eyelid.

Wynzora (calcipotriene and betamethasone dipropionate) Cream

Date of Approval: July 20, 2020
Company: MC2 Therapeutics
Treatment for: Plaque Psoriasis

Wynzora (calcipotriene and betamethasone dipropionate) is a PAD™ Cream formulation of the vitamin D analog calcipotriene, and the corticosteroid betamethasone dipropionate, indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older.

Xywav (calcium, magnesium, potassium, and sodium oxybates) Oral Solution

Date of Approval: July 21, 2020
Company: Jazz Pharmaceuticals plc
Treatment for: Narcolepsy

Xywav (calcium, magnesium, potassium, and sodium oxybates) is a low-sodium oxybate product for the treatment of cataplexy and excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.

Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) Metered Dose Inhalation

Date of Approval: July 23, 2020
Company: AstraZeneca
Treatment for: Chronic Obstructive Pulmonary Disease

Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) is a fixed dose triple-combination of the inhaled corticosteroid budesonide, the long-acting muscarinic antagonist (LAMA) glycopyrrolate, and the long-acting beta2-agonist (LABA) formoterol fumarate, delivered in a pressurized metered-dose inhaler for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Tecartus (brexucabtagene autoleucel) Suspension for Intravenous Infusion - formerly KTE-X19

Date of Approval: July 24, 2020
Company: Kite, a Gilead Company
Treatment for: Mantle Cell Lymphoma

Tecartus (brexucabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

Xeglyze (abametapir) Topical Lotion

Date of Approval: July 24, 2020
Company: Dr. Reddy’s Laboratories Ltd.
Treatment for: Head Lice

Xeglyze (abametapir) is a pediculicide indicated for the topical treatment of head lice infestation in patients 6 months of age and older.

Monjuvi (tafasitamab-cxix) for Injection

Date of Approval: July 31, 2020
Company: MorphoSys AG

Monjuvi (tafasitamab-cxix) is a CD19-directed cytolytic antibody indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

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