Most Read Articles
Dr Margaret Shi, 6 days ago

The triplet regimen of encorafenib, binimetinib and cetuximab provides significant and clinically relevant benefits in overall survival (OS) and objective response rate (ORR) in patients with BRAFV600E-mutated metastatic colorectal cancer (mCRC) who experience disease progression after one or two previous regimens, according to results of an interim analysis of the BEACON CRC trial.

Pank Jit Sin, 30 Oct 2017
Barely has the dust settled on e-cigarettes before the next cigarette replacement product, based on the heat-not-burn (HNB) principle, emerges to derail tobacco control efforts. 
Natalia Reoutova, 18 Sep 2019

A retrospective analysis of seven clinical trials demonstrated that neratinib-based therapy is safe and effective in Asian patients with metastatic HER2-positive breast cancer.

5 days ago
New drug applications approved by US FDA as of 01 - 15 November 2019 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. 

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
Dr Margaret Shi, 6 days ago

The triplet regimen of encorafenib, binimetinib and cetuximab provides significant and clinically relevant benefits in overall survival (OS) and objective response rate (ORR) in patients with BRAFV600E-mutated metastatic colorectal cancer (mCRC) who experience disease progression after one or two previous regimens, according to results of an interim analysis of the BEACON CRC trial.

Pank Jit Sin, 30 Oct 2017
Barely has the dust settled on e-cigarettes before the next cigarette replacement product, based on the heat-not-burn (HNB) principle, emerges to derail tobacco control efforts. 
Natalia Reoutova, 18 Sep 2019

A retrospective analysis of seven clinical trials demonstrated that neratinib-based therapy is safe and effective in Asian patients with metastatic HER2-positive breast cancer.

5 days ago
New drug applications approved by US FDA as of 01 - 15 November 2019 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.