2018年5月获美国食品药品管理局（FDA）新药审批的药物[盘点] - 新药热点

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2018年5月获美国食品药品管理局（FDA）新药审批的药物[盘点]

2018-10-03 14:33:14 来源: 作者: 【大中小】浏览:500次评论:0条

2018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。
PLENVU

Active Ingredient(s): polyethylene glycol (PEG) 3350; sodium ascorbate; sodium sulfate; ascorbic acid; sodium chloride; potassium chloride
Strength: 140G; 48.11G; 9G; 7.54G; 5.2G; 2.2G
Dosage Form: Solution
Company: Salix Pharms Inc.
Approval Date: 04 May 2018
Submission Classification: Type 2 - New Active Ingredient
Indication(s): Indicated for cleansing of the colon in preparation for colonoscopy in adults
Approved Label: 04/05/2018 (PDF)

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Active Ingredient(s): Lamivudine; Tenofovir disoproxil fumarate
Strength: 300MG; 300MG
Dosage Form: Tablet
Company: Aurobindo Pharma Ltd.
Approval Date: 15 May 2018
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg
Approved Label: 15/05/2018 (PDF)

RETACRIT

Active Ingredient(s): Epoetin alfa-epbx
Strength: 2,000 UNITS/ML; 3,000 UNITS/ML; 4,000 UNITS/ML; 10,000 UNITS/ML; 40,000 UNITS/ML
Dosage Form: Injectable
Company: Hospira Inc.
Approval Date: 15 May 2018
Submission Classification: Not available
Indication(s): Indicated for:
- Treatment of anemia due to
  - Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis
  - Zidovudine in patients with HIV-infection
  - The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy
- Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery
Approved Label: 15/05/2018 (PDF)

BENDAMUSTINE HYDROCHLORIDE

Active Ingredient(s): Bendamustine hydrochloride
Strength: 100 MG
Dosage Form: Injectable
Company: Eagle Pharms
Approval Date: 15 May 2018
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated for treatment of patients with:
- Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established
- Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen
Approved Label: 28/05/2018 (PDF)

LUCEMYRA

Active Ingredient(s): Lofexidine
Strength: 0.18 MG
Dosage Form: Tablet
Company: US Worldmeds LLC
Approval Date: 16 May 2018
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults
Approved Label: 16/05/2018 (PDF)

AIMOVIG

LOKELMA

DOPTELET

Active Ingredient(s): Avatrombopag
Strength: 20 MG
Dosage Form: Tablet
Company: Akarx Inc
Approval Date: 21 May 2018
Submission Classification: Type 1 - New Molecular Entity
Indication(s): Indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure
Approved Label: 21/05/2018 (PDF)

YONSA

Active Ingredient(s): Abiraterone acetate
Strength: 125 MG
Dosage Form: Tablet
Company: Sun Pharma Global
Approval Date: 22 May 2018
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer
Approved Label: 22/05/2018 (PDF)

PROGRAF

Active Ingredient(s): Tacrolimus
Strength: 0.2 MG; 1 MG
Dosage Form: Suspension
Company: Astellas
Approval Date: 24 May 2018
Submission Classification: Type 3 - New Dosage Form
Indication(s): Indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants
Approved Label: 24/05/2018 (PDF)

HALOBETASOL PROPIONATE

Active Ingredient(s): Halobetasol propionate
Strength:0.05%
Dosage Form: Fiber, extended release; periodontal
Company: Therapeutics Inc
Approval Date: 25 May 2018
Submission Classification: Type 3 - New Dosage Form and Type 4 - New Combination
Indication(s): Indicated for the topical treatment of plaque psoriasis in patients eighteen (18) years of age and older
Approved Label: 24/05/2018 (PDF)

PALYNZIQ

Active Ingredient(s): Pegvaliasee-PQPZ
Strength: 2.5MG/O.5ML; 10MG/0.5ML; 20MG/ML
Dosage Form: Injectable
Company: Biomarin Pharm
Approval Date: 25 May 2018
Submission Classification: Not available
Indication(s): Indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management
Approved Label: 24/05/2018 (PDF)

IMVEXXY

Active Ingredient(s): Estradiol
Strength:4 MCG; 10 MCG
Dosage Form: Vaginal insert
Company: TherapeuticsMD Inc
Approval Date:29 May 2018
Submission Classification: Type 5 - New Formulation or New Manufacturer
Indication(s): Indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause
Approved Label: 29/05/2018 (PDF)

CONSENSI

Active Ingredient(s): Amlodipine; Celecoxib
Strength: (2.5 MG; 200 MG); (5 MG; 200 MG); (10 MG; 200 MG)
Dosage Form: Tablet
Company: Kitov Pharmaceuticals
Approval Date: 31 May 2018
Submission Classification: Type 4 - New Combination
Indication(s): Indicated for patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate
Approved Label: 31/05/2018 (PDF)