2019年10月首次通过美国食品药品管理局新药审批的药物，包括新化学成份和新生物制剂。但未包括暂时审批的药物。药物通过新药审批后可能还需要补充申请批准。
AMZEEQ
Active Ingredient(s): Minocycline
Strength: 4%
Dosage Form(s) / Route(s):Aerosol, foam; topical
Company: Foamix Pharma, Inc.
Approval Date: 18 October 2019
Submission Classification: Not available
Indication(s): Indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
TRIKAFTA
Active Ingredient(s): Elexacaftor, tezacaftor, ivacaftor; ivacaftor
Strength: 100 mg, 75 mg, 50 mg, 150 mg
Dosage Form(s) / Route(s): Tablet; oral
Company: Vertex Pharms, Inc.
Approval Date: 21 October 2019
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the CFTR gene. If the patients's genotype is unknown, an FDA-cleared CF mutation test should be used to confirm the presence of at least one F508del mutation.
BIORPHEN
Active Ingredient(s): Phenylephrine hydrochloride
Strength: 0.1 mg/mL
Dosage Form(s) / Route(s): Injectable; injection
Company: Sintetica SA
Approval Date: 21 October 2019
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
HEMADY
Active Ingredient(s): Dexamethasone
Strength: 20 mg
Dosage Form(s) / Route(s): Tablet; oral
Company: Dexcel Pharma
Approval Date: 03 October 2019
Submission Classification: Not available
Indication(s): Indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma.
AKLIEF
Active Ingredient(s): Trifarotene
Strength: 0.005%
Dosage Form(s) / Route(s): Cream; topical
Company: Galderma Research and Dev, Inc.
Approval Date: 04 October 2019
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the topical treatment of acne vulgaris in patient 9 year of age and older.
BORTEZOMIB
Active Ingredient(s): Bortezomib
Strength: 3.5 mg
Dosage Form(s) / Route(s): Injectable; injection
Company: Dr. Reddy's Labs, Inc.
Approval Date: 04 October 2019
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated for:
treatment of adult patients with multiple myeloma.
treatment of adult patients with mantle cell lymphoma who have received at least 1 prior therapy.
QUZYTTIR
Active Ingredient(s): Cetirizine hydrochloride
Strength: 10 mg/mL
Dosage Form(s) / Route(s): Injectable; injection
Company: JDP Therapeutics, Inc.
Approval Date: 04 October 2019
Submission Classification: Type 3 - New Dosage Form
Indication(s): Indicated for the treatment of acute urticaria in adults and children 6 months of age and older.
BONSITY
Active Ingredient(s): Teriparatide
Strength: 20 ug
Dosage Form(s) / Route(s): Injectable; injection
Company: Pfenex, Inc.
Approval Date: 04 October 2019
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated for:
Treatment of postmenopausal women with osteoporosis at high risk for fracture.
Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture.
Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.
BEOVU
Active Ingredient(s): Brolucizumab-dbll
Strength: 6 mg/0.5 mL
Dosage Form(s) / Route(s): Injectable; intravitreal
Company: Novartis Pharms Corp.
Approval Date: 07 October 2019
Submission Classification: Not available
Indication(s): Indicated for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (AMD).
SCENESSE
Active Ingredient(s): Afamelanotide
Strength: 16 mg
Dosage Form(s) / Route(s): Implant; subcutaneous
Company: Clinuvel, Inc.
Approval Date: 08 October 2019
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).
FLUORODEOXYPHENYLALANINE ([18F]-DOPA)
Active Ingredient(s): Fluorodeoxyphenylalanine
Strength: 185 MBq
Dosage Form(s) / Route(s): Injectable; injection
Company: Feinstein
Approval Date: 10 October 2019
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the striatum for the evaluation of adult patients with suspected Parkinsonian syndromes (PS). Fluorodopa F 18 PET is an adjunct to other diagnostic evaluations.
REYVOW
Active Ingredient(s): Lasmiditan succinate
Strength: 50 mg, 100 mg
Dosage Form(s) / Route(s): Tablet; oral
Company: Eli Lilly and Co.
Approval Date: 11 October 2019
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the acute treatment of migraine with or without aura in adults.
SECUADO
Active Ingredient(s): Asenapine
Strength: 3.8 mg, 5.7 mg, 7.6 mg
Dosage Form(s) / Route(s): System; transdermal
Company: Hisamitsu Pharm, Co.
Approval Date: 11 October 2019
Submission Classification: Type 3 - New Dosage Form
Indication(s): Indicated for the treatment of adults with schizophrenia.
VUMERITY
Active Ingredient(s): Diroximel fumarate
Strength: 231 mg
Dosage Form(s) / Route(s): Capsule, delayed release; oral
Company: Alkermes
Approval Date: 29 October 2019
Submission Classification: Type 2 - New Active Ingredient
Indication(s): Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
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