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02 Dec 2019
Utilizing a clinical pharmacist specialist in a hepatitis C virus (HCV) treatment clinic may help improve drug therapy management of HCV-infected patients treated with direct-acting antivirals (DAAs), suggests a recent study.
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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
Pearl Toh, 03 Jan 2020
Antibiotic resistance of Helicobacter (H.) pylori has more than doubled in Europe in the past two decades, raising alarm on the gravity of the issue of growing bacterial resistance to commonly-used antibiotics, a study presented at UEG Week 2019 has shown.
02 Dec 2019
Utilizing a clinical pharmacist specialist in a hepatitis C virus (HCV) treatment clinic may help improve drug therapy management of HCV-infected patients treated with direct-acting antivirals (DAAs), suggests a recent study.
Pearl Toh, 26 Sep 2019
The Singapore Health Sciences Authority (HSA) has recalled eight brands of ranitidine products containing trace amounts of the nitrosamine impurity NDMA*, which is a potential human carcinogen.
2 days ago
The use of folic acid in addition to enalapril in the treatment of patients with hypertension yields a modest increase in lifetime stroke-free survival, a study has found.