2019年11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。IBRANCE Active Ingredient(s): PalbociclibStrength: 75 mg; 100 mg; 125 mgDosage Form(s) / Route(s): Tablet; oralCompany: Pfizer, Inc.Approval Date: 01 November 2019Submission Classification: EfficacyIndication(s):
Indicated for the treatment of adult patients with hormone receptor
(HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative
advanced or metastatic breast cancer in combination with:an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men orfulvestrant in patients with disease progression following endocrine therapy.TALICIA Active Ingredient(s): Omeprazole magnesium; amoxicilin; rifabutinStrength: 10 mg/250 mg/12.5 mgDosage Form(s) / Route(s): Capsule, delayed release; oralCompany: Redhill Biopharma, Ltd.Approval Date: 01 November 2019Submission Classification: Type 4 - New CombinationIndication(s):
Indicated for the treatment of Helicobacter pylori infection in adults.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of TALICIA and other antibacterial drugs, TALICIA should
be used only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria. ZIEXTENZO Active Ingredient(s): Pegfilgrastim-bmezStrength: 6 mg/0.6 mLDosage Form(s) / Route(s): Injectable; injectionCompany: Sandoz, Inc.Approval Date: 04 November 2019Submission Classification: Not availableIndication(s):
Indicated to decrease the incidence of infection, as manifested by
febrile neutropenia, in patients with non-myeloid malignancies receiving
myelosuppressive anti-cancer drugs associated with a clinically
significant incidence of febrile neutropenia.EPINEPHRINE Active Ingredient(s): EpinephrineStrength: 1 mg/10 mLDosage Form(s) / Route(s): Injectable; injectionCompany: Hospira, Inc.Approval Date: 05 November 2019Submission Classification: Type 7 - Drug Already Marketed without Approved NDAIndication(s):Not availableABSORICA LD Active Ingredient(s): IsotretinoinStrength: 8 mg; 16 mg; 20 mg; 24 mg; 28 mg; 32 mgDosage Form(s) / Route(s): Capsule; oralCompany: Sun Pharm Inds Ltd.Approval Date: 05 November 2019Submission Classification: Not availableIndication(s):
Indicated for the treatment of severe recalcitrant nodular acne in
non-pregnant patients 12 years of age and older with multiple
inflammatory nodules with diameter of 5 mm or greater. Because of
significant adverse reactions associated with its use, ABSORICA and
ABSORICA LD are reserved for patients with severe nodular acne who are
unresponsive to conventional therapy, including systemic antibiotics.EXEM FOAM Active Ingredient(s): Air polymer-type AStrength: 5 mLDosage Form(s) / Route(s): Foam; intrauterineCompany: Giskit B.V.Approval Date: 07 November 2019Submission Classification: Type 1 - New Molecular EntityIndication(s): Indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility.REBLOZYLActive Ingredient(s): Luspatercept-aamtStrength: 25 mg/vial; 75 mg/vialDosage Form(s) / Route(s): Powder; subcutaneousCompany: Celgene CorpApproval Date: 08 November 2019Submission Classification: Not availableIndication(s): Indicated for the treatment of anemia in:Adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.BRUKINSA Active Ingredient(s): ZanubrutinibStrength: 160 mg; 320 mgDosage Form(s) / Route(s): Capsule; oralCompany: Beigene USA, Inc.Approval Date: 14 November 2019Submission Classification: Type 1 - New Molecular EntityIndication(s): Indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. FETROJA Active Ingredient(s): CefiderocolStrength: 1 g/vialDosage Form(s) / Route(s): Powder; intravenousCompany: Shionogi, Inc.Approval Date: 14 November 2019Submission Classification: Type 1 - New Molecular EntityIndication(s): Indicated
in patients 18 years of age or older who have limited or no alternative
treatment options, for the treatment of complicated urinary tract
infections (cUTI), including pyelonephritis caused by susceptible
Gram-negative microorganisms.ADAKVEO Active Ingredient(s): Crizanlizumab-tmcaStrength: 100 mg/10 mLDosage Form(s) / Route(s): Injectable; injectionCompany: Novartis Pharms Corp.Approval Date: 15 November 2019Submission Classification: Not availableIndication(s):
Indicated to reduce the frequency of vasoocclusive crises in adults and
pediatric patients aged 16 years and older with sickle cell disease.ABRILADA Active Ingredient(s): Adalimumab-afzbStrength: 40 mg/0.8 mL; 20 mg/0.4 mL; 10 mg/0.2 mLDosage Form(s) / Route(s): Injectable; injectionCompany: Pfizer, Inc.Approval Date: 15 November 2019Submission Classification: Not availableIndication(s): Indicated for treatment of:Rheumatoid Arthritis
