Most Read Articles
15 Sep 2018
Prenatal and postpartum vitamin D supplementation does not appear to improve foetal or infant growth, a study reports.
13 Sep 2018
Excessive daytime sleepiness appears to increase the long-term risk of amyloid β (Aβ) deposition, a recent study has shown.
Tristan Manalac, 2 days ago
The causes, presentations and management of anaphylaxis vary considerably with age, according to a recent Singapore study, which reported that children are more likely to present with food anaphylaxis, while drug anaphylaxis is more common in adults.
13 Sep 2018
Substituting diets high in carbohydrates with those high in monounsaturated fatty acids in the context of low saturated fatty acids do not appear to yield favourable effects on blood pressure, according to a meta-analysis.

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
15 Sep 2018
Prenatal and postpartum vitamin D supplementation does not appear to improve foetal or infant growth, a study reports.
13 Sep 2018
Excessive daytime sleepiness appears to increase the long-term risk of amyloid β (Aβ) deposition, a recent study has shown.
Tristan Manalac, 2 days ago
The causes, presentations and management of anaphylaxis vary considerably with age, according to a recent Singapore study, which reported that children are more likely to present with food anaphylaxis, while drug anaphylaxis is more common in adults.
13 Sep 2018
Substituting diets high in carbohydrates with those high in monounsaturated fatty acids in the context of low saturated fatty acids do not appear to yield favourable effects on blood pressure, according to a meta-analysis.