Most Read Articles
Audrey Abella, 14 Jun 2019
The taxane-based TPEx regimen demonstrated encouraging overall survival (OS) benefit for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) compared with the fluorouracil (5FU)-based EXTREME regimen, according to the results of the TPExtreme* trial presented at ASCO 2019.
Christina Lau, 18 Jun 2019

Patients with previously untreated metastatic nonsquamous non-small-cell lung cancer (NSCLC) may have their overall survival (OS) and progression-free survival (PFS) approximately doubled with pembrolizumab in combination with platinum-based chemotherapy vs chemotherapy alone, according to updated results of the KEYNOTE-189 trial reported at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.

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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Most Read Articles
Audrey Abella, 14 Jun 2019
The taxane-based TPEx regimen demonstrated encouraging overall survival (OS) benefit for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) compared with the fluorouracil (5FU)-based EXTREME regimen, according to the results of the TPExtreme* trial presented at ASCO 2019.
Christina Lau, 18 Jun 2019

Patients with previously untreated metastatic nonsquamous non-small-cell lung cancer (NSCLC) may have their overall survival (OS) and progression-free survival (PFS) approximately doubled with pembrolizumab in combination with platinum-based chemotherapy vs chemotherapy alone, according to updated results of the KEYNOTE-189 trial reported at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.