2019年10月初次根据美国食品药品管理局新药审批的药物，包含新有机化学成分和新生物制品。但未包含临时审批的药物。药物根据新药审批后将会还必须填补申请办理准许。AMZEEQ Active Ingredient(s): MinocyclineStrength: 4%Dosage Form(s) / Route(s):Aerosol, foam; topicalCompany: Foamix Pharma, Inc.Approval Date: 18 October 2019Submission Classification: Not availableIndication(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; ivacaftorStrength: 100 mg, 75 mg, 50 mg, 150 mgDosage Form(s) / Route(s): Tablet; oralCompany: Vertex Pharms, Inc.Approval Date: 21 October 2019Submission Classification: Type 1 - New Molecular EntityIndication(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 hydrochlorideStrength: 0.1 mg/mLDosage Form(s) / Route(s): Injectable; injectionCompany: Sintetica SAApproval Date: 21 October 2019Submission Classification: Type 5 - New Formulation or New ManufacturerIndication(s):
Indicated for the treatment of clinically important hypotension
resulting primarily from vasodilation in the setting of anesthesia.HEMADY Active Ingredient(s): DexamethasoneStrength: 20 mgDosage Form(s) / Route(s): Tablet; oralCompany: Dexcel PharmaApproval Date: 03 October 2019Submission Classification: Not availableIndication(s): Indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma.AKLIEF Active Ingredient(s): TrifaroteneStrength: 0.005%Dosage Form(s) / Route(s): Cream; topicalCompany: Galderma Research and Dev, Inc.Approval Date: 04 October 2019Submission Classification: Type 1 - New Molecular EntityIndication(s): Indicated for the topical treatment of acne vulgaris in patient 9 year of age and older.BORTEZOMIB Active Ingredient(s): BortezomibStrength: 3.5 mgDosage Form(s) / Route(s): Injectable; injectionCompany: Dr. Reddy's Labs, Inc.Approval Date: 04 October 2019Submission Classification: Type 5 - New Formulation or New ManufacturerIndication(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 hydrochlorideStrength: 10 mg/mLDosage Form(s) / Route(s): Injectable; injectionCompany: JDP Therapeutics, Inc.Approval Date: 04 October 2019Submission Classification: Type 3 - New Dosage FormIndication(s): Indicated for the treatment of acute urticaria in adults and children 6 months of age and older.BONSITY Active Ingredient(s): TeriparatideStrength: 20 ugDosage Form(s) / Route(s): Injectable; injectionCompany: Pfenex, Inc.Approval Date: 04 October 2019Submission Classification: Type 5 - New Formulation or New ManufacturerIndication(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-dbllStrength: 6 mg/0.5 mLDosage Form(s) / Route(s): Injectable; intravitrealCompany: Novartis Pharms Corp.Approval Date: 07 October 2019Submission Classification: Not availableIndication(s): Indicated for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (AMD).SCENESSE Active Ingredient(s): AfamelanotideStrength: 16 mgDosage Form(s) / Route(s): Implant; subcutaneousCompany: Clinuvel, Inc.Approval Date: 08 October 2019Submission Classification: Type 1 - New Molecular EntityIndication(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): FluorodeoxyphenylalanineStrength: 185 MBqDosage Form(s) / Route(s): Injectable; injectionCompany: FeinsteinApproval Date: 10 October 2019Submission Classification: Type 1 - New Molecular EntityIndication(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 succinateStrength: 50 mg, 100 mgDosage Form(s) / Route(s): Tablet; oralCompany: Eli Lilly and Co.Approval Date: 11 October 2019Submission Classification: Type 1 - New Molecular EntityIndication(s): Indicated for the acute treatment of migraine with or without aura in adults.SECUADO Active Ingredient(s): AsenapineS
