2019年11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。
IBRANCE
Active Ingredient(s): Palbociclib
Strength: 75 mg; 100 mg; 125 mg
Dosage Form(s) / Route(s): Tablet; oral
Company: Pfizer, Inc.
Approval Date: 01 November 2019
Submission Classification: Efficacy
Indication(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 or
fulvestrant in patients with disease progression following endocrine therapy.
TALICIA
Active Ingredient(s): Omeprazole magnesium; amoxicilin; rifabutin
Strength: 10 mg/250 mg/12.5 mg
Dosage Form(s) / Route(s): Capsule, delayed release; oral
Company: Redhill Biopharma, Ltd.
Approval Date: 01 November 2019
Submission Classification: Type 4 - New Combination
Indication(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-bmez
Strength: 6 mg/0.6 mL
Dosage Form(s) / Route(s): Injectable; injection
Company: Sandoz, Inc.
Approval Date: 04 November 2019
Submission Classification: Not available
Indication(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): Epinephrine
Strength: 1 mg/10 mL
Dosage Form(s) / Route(s): Injectable; injection
Company: Hospira, Inc.
Approval Date: 05 November 2019
Submission Classification: Type 7 - Drug Already Marketed without Approved NDA
Indication(s):Not available
ABSORICA LD
Active Ingredient(s): Isotretinoin
Strength: 8 mg; 16 mg; 20 mg; 24 mg; 28 mg; 32 mg
Dosage Form(s) / Route(s): Capsule; oral
Company: Sun Pharm Inds Ltd.
Approval Date: 05 November 2019
Submission Classification: Not available
Indication(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 A
Strength: 5 mL
Dosage Form(s) / Route(s): Foam; intrauterine
Company: Giskit B.V.
Approval Date: 07 November 2019
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for sonohysterosalpingography to assess fallopian tube patency in women with known or suspected infertility.
REBLOZYL
Active Ingredient(s): Luspatercept-aamt
Strength: 25 mg/vial; 75 mg/vial
Dosage Form(s) / Route(s): Powder; subcutaneous
Company: Celgene Corp
Approval Date: 08 November 2019
Submission Classification: Not available
Indication(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): Zanubrutinib
Strength: 160 mg; 320 mg
Dosage Form(s) / Route(s): Capsule; oral
Company: Beigene USA, Inc.
Approval Date: 14 November 2019
Submission Classification: Type 1 - New Molecular Entity
Indication(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): Cefiderocol
Strength: 1 g/vial
Dosage Form(s) / Route(s): Powder; intravenous
Company: Shionogi, Inc.
Approval Date: 14 November 2019
Submission Classification: Type 1 - New Molecular Entity
Indication(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-tmca
Strength: 100 mg/10 mL
Dosage Form(s) / Route(s): Injectable; injection
Company: Novartis Pharms Corp.
Approval Date: 15 November 2019
Submission Classification: Not available
Indication(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-afzb
Strength: 40 mg/0.8 mL; 20 mg/0.4 mL; 10 mg/0.2 mL
Dosage Form(s) / Route(s): Injectable; injection
Company: Pfizer, Inc.
Approval Date: 15 November 2019
Submission Classification: Not available
Indication(s): Indicated for treatment of:
Rheumatoid Arthritis (RA): Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
Juvenile Idiopathic Arthritis (JIA): Reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 4 years of age and older.
Psoriatic Arthritis (PsA): Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
Ankylosing Spondylitis (AS): Reducing signs and symptoms in adult patients with active AS.
Adult Crohn's Disease (CD): Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab products.
Ulcerative Colitis (UC): Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers.
Plaque Psoriasis (Ps): The treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
GIVLAARI
Active Ingredient(s): Givosiran sodium
Strength: 189 mg/mL
Dosage Form(s) / Route(s): Injectable; injection
Company: Alnylam Pharms, Inc.
Approval Date: 20 November 2019
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the treatment of adults with acute hepatic porphyria (AHP).
XCOPRI
Active Ingredient(s): Cenobamate
Strength: 12.5 mg; 25 mg; 50 mg; 100 mg; 150 mg; 200 mg
Dosage Form(s) / Route(s): Tablet; oral
Company: SK Life Science, Inc.
Approval Date: 21 November 2019
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the treatment of partial-onset seizures in adult patients.
EXSERVAN
Active Ingredient(s): Riluzole
Strength: 50 mg
Dosage Form(s) / Route(s): Film; oral
Company: Aquestive Therap
Approval Date: 22 November 2019
Submission Classification: Type 3 - New Dosage Form
Indication(s): Indicated for the treatment of amyotrophic lateral sclerosis (ALS).
OXBRYTA
Active Ingredient(s): Voxelotor
Strength: 500 mg
Dosage Form(s) / Route(s): Tablet; oral
Company: Global Blood Therapeutics, Inc.
Approval Date: 25 November 2019
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the treatment of sickle cell disease in adults and pediatric patients 12 years of age and older.
POTASSIUM PHOSPHATES
Active Ingredient(s): Potassium phosphates
Strength: 3 mmol/mL; 4.4 mEq/mL
Dosage Form(s) / Route(s): Injectable; injection
Company: Fresenius Kabi USA
Approval Date: 27 November 2019
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated as a source of phosphorus:
in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated.
for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.
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