Most Read Articles
4 days ago
Combining the DASH (Dietary Approaches to Stop Hypertension) diet with low sodium intake reduces systolic blood pressure (SBP) in individuals with pre- and stage 1 hypertension, with progressively higher reductions at greater levels of baseline SBP, a recent study has shown.
Tristan Manalac, 2 days ago
Major depressive disorder (MDD) appears to be more prevalent in females than in males, particularly in those who are divorced or widowed, a recent study from Singapore has found.
3 days ago
Tadalafil may not be effective for reducing the decline in ambulatory ability in boys with Duchenne muscular dystrophy (DMD), as shown in a recent study.
6 days ago
Hydrochlorothiazide (HCTZ) appears to significantly increase the risks of nonmelanoma skin cancer (NMSC), particularly squamous cell carcinoma (SCC), a recent study has shown.

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
4 days ago
Combining the DASH (Dietary Approaches to Stop Hypertension) diet with low sodium intake reduces systolic blood pressure (SBP) in individuals with pre- and stage 1 hypertension, with progressively higher reductions at greater levels of baseline SBP, a recent study has shown.
Tristan Manalac, 2 days ago
Major depressive disorder (MDD) appears to be more prevalent in females than in males, particularly in those who are divorced or widowed, a recent study from Singapore has found.
3 days ago
Tadalafil may not be effective for reducing the decline in ambulatory ability in boys with Duchenne muscular dystrophy (DMD), as shown in a recent study.
6 days ago
Hydrochlorothiazide (HCTZ) appears to significantly increase the risks of nonmelanoma skin cancer (NMSC), particularly squamous cell carcinoma (SCC), a recent study has shown.