Most Read Articles
Roshini Claire Anthony, 02 Feb 2018

The use of weight loss medications for at least 1 year did little to improve cardiometabolic risk factors in obese adults, according to a systematic review and meta-analysis.

17 Feb 2019
In patients with type 2 diabetes (T2D), sodium-glucose cotransporter 2 (SGLT2) inhibitor monotherapy, particularly canagliflozin, exerts greater effects on weight compared with metformin and dipeptidyl peptidase 4 (DPP-4) inhibitors or gliptins, according to the results of a meta-analysis.
26 Feb 2019
Oral fluoxetine confers beneficial effects in the management of adult and adolescent amblyopia, suggests a recent study.
19 Feb 2019
Preprandial administration of metformin successfully and safely reduces postprandial plasma triglyceride levels, a new study has shown.

Original New Drug Application Approvals by US FDA (01 - 15 August 2019)

15 Aug 2019
New drug applications approved by US FDA as of 01 - 15 August 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.

TURALIO
  • Active Ingredient(s): Pexidartinib
  • Strength: 200 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Daiichi Sankyo Inc.
  • Approval Date: 02 August 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amendable to improvement with surgery. 
  • Approved Label02 August 2019 (PDF)

PRETOMANID
  • Active Ingredient(s): Pretomanid
  • Strength: 200 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: The Global Alliance for TB Drug Dev
  • Approval Date: 14 August 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated, as part of a combination regimen with bedaquiline and linezolid for the treatment of adults with pulmonary extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB). Approval of this indication is based on limited clinical safety and efficacy data. This drug is indicated for use in a limited and specific population of patients.
  • Approved Label14 August 2019 (PDF)

WAKIX
  • Active Ingredient(s): Pitolisant hydrochloride
  • Strength: 4.45 mg; 17.4 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Bioprojet Pharma
  • Approval Date: 14 August 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. 
  • Approved Label14 August 2019 (PDF)

ROZLYTREK
  • Active Ingredient(s): Entrectinib
  • Strength: 100 mg; 200 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Genentech Inc.
  • Approval Date: 15 August 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of:
    • Adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.
    • Adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation; are metastatic or where surgical resection is likely to result in severe morbidity; and have progressed following treatment or have no satisfactory alternative therapy. This indication is approved under accelerated approval based on tumor response rate durability o response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
  • Approved Label15 August 2019 (PDF)
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Most Read Articles
Roshini Claire Anthony, 02 Feb 2018

The use of weight loss medications for at least 1 year did little to improve cardiometabolic risk factors in obese adults, according to a systematic review and meta-analysis.

17 Feb 2019
In patients with type 2 diabetes (T2D), sodium-glucose cotransporter 2 (SGLT2) inhibitor monotherapy, particularly canagliflozin, exerts greater effects on weight compared with metformin and dipeptidyl peptidase 4 (DPP-4) inhibitors or gliptins, according to the results of a meta-analysis.
26 Feb 2019
Oral fluoxetine confers beneficial effects in the management of adult and adolescent amblyopia, suggests a recent study.
19 Feb 2019
Preprandial administration of metformin successfully and safely reduces postprandial plasma triglyceride levels, a new study has shown.