Most Read Articles
Stephen Padilla, 12 Dec 2019
Transitioning from bortezomib- to ixazomib-based induction is feasible, tolerable and effective in the treatment of community patients with newly diagnosed multiple myeloma (NDMM), according to a study presented at the 61st Annual Meeting of the American Society of Hematology (ASH 2019).
10 Mar 2017
The addition of pravastatin to standard chemotherapy does not improve outcomes in patients with small-cell lung cancer (SCLC), results of a study have shown.
Tristan Manalac, 03 Dec 2019
Incorporating basic tumour characteristics, such as hormone receptor status and tumour origin, improves the power of the cell-loss metric to predict response to treatment, according to a new study presented at the recently concluded 2019 Asia Congress of the European Society for Medical Oncology (ESMO Asia 2019).
Audrey Abella, 2 days ago
A moderately hypofractionated radiotherapy (RT) dose schedule was noninferior to conventional RT, according to the 8-year outcomes from the CHHiP* trial presented at ASCO GU 2020.

Original New Drug Application Approvals by US FDA (16 - 30 June 2018)

30 Jun 2018

New drug applications approved by US FDA as of 16-30 June 2018 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.

NOCDURNA

  • Active Ingredient(s): Desmopressin Acetate
  • Strength: 27.7 mcg; 53.3 mcg
  • Dosage Form: Tablet; sublingual
  • Company: Ferring Pharms Inc
  • Approval Date: June 21, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for r the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void. 
  • Approved Label: 06/21/2018(PDF)
ABLYSINOL
  • Active Ingredient(s): Dehydrated Alcohol
  • Strength: 1 ml; 5 ml
  • Dosage Form: Injectable; injection
  • Company: Belcher Pharms LLC
  • Approval Date: June 21, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not Applicable
  • Approved Label: Not Applicable 
ZEMDRI
  • Active Ingredient(s): Plazomicin
  • Strength: 50 mg/ml
  • Dosage Form: Injectable; injection
  • Company: Achaogen Inc
  • Approval Date: June 25, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of patients 18 years of age or older with Complicated Urinary Tract Infections (cUTI) including Pyelonephritis. 
  • Approved Label: 06/25/2018(PDF)
EPIDIOLEX
  • Active Ingredient(s): Cannabidiol
  • Strength: 100 mg/ml
  • Dosage Form: Solution; oral
  • Company: GW Research Ltd
  • Approval Date: June 25, 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated  of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older.
  • Approved Label: 06/25/2018(PDF)
BRAFTOVI
  • Active Ingredient(s): Encorafenib
  • Strength: 50 mg; 75 mg
  • Dosage Form: Capsule; oral
  • Company: Array Biopharma Inc
  • Approval Date: June 27, 2018
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Indicated  for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test 
  • Approved Label: 06/27/2018(PDF)
MEKTOVI
  • Active Ingredient(s): Binimetinib
  • Strength: 15 mg
  • Dosage Form: Tablet; oral
  • Company: Array Biopharma Inc
  • Approval Date: June 27, 2018
  • Submission Classification: Type 1 - New Molecular Entity and Type 4 - New Combination
  • Indication(s): Not applicable
  • Approved Label: Not Applicable 
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Editor's Recommendations
Most Read Articles
Stephen Padilla, 12 Dec 2019
Transitioning from bortezomib- to ixazomib-based induction is feasible, tolerable and effective in the treatment of community patients with newly diagnosed multiple myeloma (NDMM), according to a study presented at the 61st Annual Meeting of the American Society of Hematology (ASH 2019).
10 Mar 2017
The addition of pravastatin to standard chemotherapy does not improve outcomes in patients with small-cell lung cancer (SCLC), results of a study have shown.
Tristan Manalac, 03 Dec 2019
Incorporating basic tumour characteristics, such as hormone receptor status and tumour origin, improves the power of the cell-loss metric to predict response to treatment, according to a new study presented at the recently concluded 2019 Asia Congress of the European Society for Medical Oncology (ESMO Asia 2019).
Audrey Abella, 2 days ago
A moderately hypofractionated radiotherapy (RT) dose schedule was noninferior to conventional RT, according to the 8-year outcomes from the CHHiP* trial presented at ASCO GU 2020.