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New Drug Approvals Archive - October 2019

See also: New Indications and Dosage Forms for October 2019

October 2019

Aklief (trifarotene) Topical Cream

Date of Approval: October 4, 2019
Company: Galderma
Treatment for: Acne

Aklief (trifarotene) is a topical retinoid indicated for the treatment of acne vulgaris in patients 9 years of age and older.

Bonsity (teriparatide) Injection - formerly PF708

Date of Approval: October 4, 2019
Company: Pfenex Inc.
Treatment for: Osteoporosis

Bonsity (teriparatide) is a parathyroid hormone analog (PTH 1-34) indicated for the treatment of osteoporosis in certain patients at high risk for fracture.

Scenesse (afamelanotide) Implant

Date of Approval: October 8, 2019
Company: Clinuvel Pharmaceuticals Ltd.
Treatment for: Prevention of Phototoxicity in Erythropoietic Protoporphyria

Scenesse (afamelanotide) is a selective agonist of the melanocortin 1 receptor (MC1R) indicated for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).

Beovu (brolucizumab-dbll) Injection

Date of Approval: October 7, 2019
Company: Novartis
Treatment for: Macular Degeneration

Beovu (brolucizumab-dbll) is a human vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).

Quzyttir (cetirizine hydrochloride) Injection

Date of Approval: October 4, 2019
Company: TerSera Therapeutics LLC
Treatment for: Urticaria

Quzyttir (cetirizine hydrochloride) is a histamine-1 (H1) receptor antagonist indicated for the treatment of acute urticaria in adults and children 6 months of age and older.

Reyvow (lasmiditan) Tablets

Date of Approval: October 11, 2019
Company: Eli Lilly and Company
Treatment for: Migraine

Reyvow (lasmiditan) is a serotonin (5-HT)1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults.

Secuado (asenapine) Transdermal System

Date of Approval: October 11, 2019
Company: Noven Pharmaceuticals, Inc.
Treatment for: Schizophrenia

Secuado (asenapine) is a transdermal atypical antipsychotic formulation indicated for the treatment of adults with schizophrenia.

Amzeeq (minocycline) Topical Foam

Date of Approval: October 18, 2019
Company: Foamix Pharmaceuticals
Treatment for: Acne

Amzeeq (minocycline) is a topical foam formulation of the approved tetracycline drug minocycline indicated for the treatment of moderate to severe acne vulgaris in patients 9 years of age and older.

Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) Tablets

Date of Approval: October 21, 2019
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis

Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a triple combination regimen for the treatment of cystic fibrosis (CF) in patients ages 12 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Biorphen (phenylephrine hydrochloride) Injection

Date of Approval: October 21, 2019
Company: Eton Pharmaceuticals, Inc.
Treatment for: Hypotension

Biorphen (phenylephrine hydrochloride) injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of hypotension during anesthesia.

Vumerity (diroximel fumarate) Delayed-Release Capsules

Date of Approval: October 29, 2019
Company: Alkermes plc and Biogen
Treatment for: Multiple Sclerosis

Vumerity (diroximel fumarate) is a novel oral fumarate for the treatment of relapsing forms of multiple sclerosis (MS).

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