Most Read Articles
2 days ago
Exposure to corticosteroids in patients with autoimmune hepatitis (AIH) appears to contribute to increased risks of cataract, diabetes and bone fractures, a study has found. Notably, the fracture risk is elevated at low doses, while the risk of adverse events overall is dose-dependent and is reversible.
6 days ago
In patients with atrial fibrillation (AF) and stable coronary artery disease (CAD), rivaroxaban monotherapy is noninferior to combination treatment with an antiplatelet therapy in terms of cutting the risk of cardiovascular events and mortality, according to data from the AFIRE trial.
Elvira Manzano, 12 Nov 2019
Supplementation with omega-3 fatty acids or vitamin D3 for up to 5 years has no effect on kidney function in adults with type 2 diabetes (T2D), the VITAL-DKD* ancillary study has shown.
Jairia Dela Cruz, 5 days ago
Many patients with nonvalvular atrial fibrillation (NVAF) in Thailand use anticoagulants, but the uptake of nonvitamin-K oral anticoagulants remains suboptimal despite showing an upward trend, according to data from the COOL-AF registry presented at the European Society of Cardioloy (ESC) Asia Congress 2019 with APSC and AFC.

Original New Drug Application Approvals by US FDA (1- 15 August 2017)

15 Aug 2017
New drug applications approved by US FDA as of 1 - 15 August 2017 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

IDHIFA
  • Active Ingredient(s): ENASIDENIB
  • Strength: 50MG; 100MG
  • Dosage Form: Oral tablet
  • Company: Celgene Corp
  • Approval Date: August 1, 2017
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test
  • Approved Label: 08/01/2017 (PDF)

DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE
  • Active Ingredient(s): DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE
  • Strength: 50MG;300MG;300MG
  • Dosage Form: Oral tablet
  • Company: Mylan Pharms Inc
  • Approval Date: August 2, 2017
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated for the treatment of HIV-1 infection alone as a complete regimen in adults and pediatric patients weighing 40 kg and greater
  • Approved Label: Not available

QVAR
  • Active Ingredient(s): BECLOMETHASONE DIPROPIONATE
  • Strength: 40MCG; 80MCG
  • Dosage Form: Oral aerosol
  • Company: Norton Waterford Ltd
  • Approval Date: August 3, 2017
  • Submission Classification: Not available
  • Indication(s): Indicated for maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older
  • Approved Label: 08/03/2017 (PDF)

MAVYRET
  • Active Ingredient(s): GLECAPREVIR;PIBRENTASVIR
  • Strength: 100MG;40MG
  • Dosage Form: Oral tablet
  • Company: Abbvie Inc
  • Approval Date: August 3, 2017
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated for
    • treatment of patients with chronic HCV genotype (GT) 1, 2, 3, 4, 5 or 6 infection without cirrhosis and with compensated cirrhosis (Child-Pugh A)
    • treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both
  • Approved Label: 08/03/2017 (PDF)

VYXEOS
  • Active Ingredient(s): DAUNORUBICIN;CYTARABINE
  • Strength: 44MG;100MG
  • Dosage Form: Injectable, Liposomal; Iinjection
  • Company: Celator Pharma Inc
  • Approval Date: August 3, 2017
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC)
  • Approved Label: 08/03/2017 (PDF)

GEMCITABINE
  • Active Ingredient(s): GEMCITABINE
  • Strength: 100MG/ML
  • Dosage Form: Injectable; Injection
  • Company: Accord Hlthcare Inc
  • Approval Date: August 3, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated
    • in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy
    • in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated
    • in combination with cisplatin for the treatment of non-small cell lung cancer
    • as a single agent for the treatment of pancreatic cancer
  • Approved Label: 08/03/2017 (PDF)

CAROSPIR
  • Active Ingredient(s): SPIRONOLACTONE
  • Strength: 25MG/5ML
  • Dosage Form: Oral suspension
  • Company: CMP Pharma Inc
  • Approval Date: August 4, 2017
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for:
    • the treatment of NYHA Class III-IV heart failure and reduce dejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure
    • use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions
    • the management of edema in adult cirrhotic patients when edema is not responsive to fluid and sodium restrictions
  • Approved Label: 08/04/2017 (PDF)

NIKITA
  • Active Ingredient(s): PITAVASTATIN
  • Strength: 1MG; 2MG; 4MG
  • Dosage Form: Oral tablet
  • Company: Lupin Ltd
  • Approval Date: August 4, 2017
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Indicated for:
    • Patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C)
  • Approved Label: 08/04/2017 (PDF)

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Most Read Articles
2 days ago
Exposure to corticosteroids in patients with autoimmune hepatitis (AIH) appears to contribute to increased risks of cataract, diabetes and bone fractures, a study has found. Notably, the fracture risk is elevated at low doses, while the risk of adverse events overall is dose-dependent and is reversible.
6 days ago
In patients with atrial fibrillation (AF) and stable coronary artery disease (CAD), rivaroxaban monotherapy is noninferior to combination treatment with an antiplatelet therapy in terms of cutting the risk of cardiovascular events and mortality, according to data from the AFIRE trial.
Elvira Manzano, 12 Nov 2019
Supplementation with omega-3 fatty acids or vitamin D3 for up to 5 years has no effect on kidney function in adults with type 2 diabetes (T2D), the VITAL-DKD* ancillary study has shown.
Jairia Dela Cruz, 5 days ago
Many patients with nonvalvular atrial fibrillation (NVAF) in Thailand use anticoagulants, but the uptake of nonvitamin-K oral anticoagulants remains suboptimal despite showing an upward trend, according to data from the COOL-AF registry presented at the European Society of Cardioloy (ESC) Asia Congress 2019 with APSC and AFC.