2017年5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。
STERITALC
•Active Ingredient(s): TALC
•Strength: 2 mg, 3 mg, 4 mg
•Dosage Form: Topical Powder
•Company: Novatech SA
•Approval Date: May 1, 2017
•Chemical Type: Type 5 - New Formulation or New Manufacturer
•Indication(s): Indicated: ◦To decrease the recurrence of malignant pleural effusions in symptomatic patients following maximal drainage of the pleural effusion.
◦In adults to decrease the recurrence of pneumothorax
•Approved Label:05/01/2017 (PDF)
IMFINZI
•Active Ingredient(s): DURVALUMAB
•Strength: 50 mg/mL
•Dosage Form: Injectable; Injection
•Company: Astrazeneca UK Ltd
•Approval Date: May 1, 2017
•Chemical Type: Not available
•Indication(s): Indicated for the treatment of patients with: ◦Locally advanced or metastatic urothelial carcinoma who: ◾have disease progression during or following platinum-containing chemotherapy
◾have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
•Approved Label:05/01/2017 (PDF)
KISQALI; FEMARA
•Active Ingredient(s): LETROZOLE; RIBOCICLIB
•Strength: 200 mg
•Dosage Form: Oral Tablet
•Company: Novartis Pharms Corp
•Approval Date: May 4, 2017
•Chemical Type: Type 4 - New Combination
•Indication(s): Indicated as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
•Approved Label:05/04/2017 (PDF)
RADICAVA
•Active Ingredient(s): EDARAVONE
•Strength: 30 mg/100 mL
•Dosage Form: Injectable; Injection
•Company: Mitsubishi Tanabe Pharma Development America Inc
•Approval Date: May 5, 2017
•Chemical Type: Type 1 - New Molecular Entity
•Indication(s): Indicated for the treatment of amyotrophic lateral sclerosis (ALS)
•Approved Label:05/05/2017 (PDF)
MINOLIRA
•Active Ingredient(s): MINOCYCLINE HYDROCHLORIDE
•Strength: 105 mg, 135 mg
•Dosage Form: Extended release oral tablet
•Company: Dr Reddys Labs Ltd
•Approval Date: May 8, 2017
•Chemical Type: Type 5 - New Formulation or New Manufacturer
•Indication(s): Indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older
•Approved Label:05/05/2017 (PDF)
BAVENCIO
•Active Ingredient(s): AVELUMAB
•Strength: 20 mg/mL
•Dosage Form: Injectable; Intravenoues
•Company: EMD Serono Inc
•Approval Date: May 9, 2017
•Chemical Type: Not available
•Indication(s): Indicated for the treatment of: ◦Adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC)
◦Patients with locally advanced or metastatic urothelial carcinoma (UC) who: ◾Have disease progression during or following platinum-containing chemotherapy
◾Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
•Approved Label:05/09/2017 (PDF)
JADENU SPRINKLE
•Active Ingredient(s): DEFERASIROX
•Strength: 90 mg; 180 mg
•Dosage Form: Oral granule
•Company: Novartis Pharms Corp
•Approval Date: May 18, 2017
•Chemical Type: Type 5 - New Formulation or New Manufacturer
•Indication(s): Indicated for ◦the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older
◦the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight (Fe/g dw) and a serum ferritin greater than 300 mcg/L
•Approved Label:05/18/2017 (PDF)
KEVZARA
•Active Ingredient(s): SARILUMAB
•Strength: 150 mg/1.14 mL; 200 mg/1.14 mL
•Dosage Form: Injectable; Injection
•Company: Sanofi Synthelabo
•Approval Date: May 22, 2017
•Chemical Type: Not available
•Indication(s): Indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).
•Approved Label:05/22/2017 (PDF) |
