Most Read Articles
Stephen Padilla, 25 Jul 2019
Nonvitamin K antagonist oral anticoagulants (NOACs) appear to confer more clinical benefits to elderly patients with atrial fibrillation (AF) than vitamin K antagonist anticoagulants (VKAs), suggests a study, adding that this is primarily driven by the lower rates of major bleeding.
22 Aug 2018
In patients with atrial fibrillation (AF) naïve to oral anticoagulants (OACs), standard-dose nonvitamin K antagonist OACs (NOACs) provides better survival benefits than warfarin, a recent meta-analysis has shown.
Stephen Padilla, 31 Aug 2018
Treatment with rivaroxaban results in less recurrent venous thromboembolism (VTE) in frail patients with VTE, with similar good bleeding outcomes, compared with warfarin, reports a study.
Stephen Padilla, 11 Sep 2018
Use of diclofenac, a traditional nonsteroidal anti-inflammatory drug (NSAID) with cyclo-oxygenase-2 (COX-2) selectivity similar to COX-2 inhibitors, is associated with higher cardiovascular health risk compared with nonuse, paracetamol use and use of other traditional NSAIDs, a recent 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
Stephen Padilla, 25 Jul 2019
Nonvitamin K antagonist oral anticoagulants (NOACs) appear to confer more clinical benefits to elderly patients with atrial fibrillation (AF) than vitamin K antagonist anticoagulants (VKAs), suggests a study, adding that this is primarily driven by the lower rates of major bleeding.
22 Aug 2018
In patients with atrial fibrillation (AF) naïve to oral anticoagulants (OACs), standard-dose nonvitamin K antagonist OACs (NOACs) provides better survival benefits than warfarin, a recent meta-analysis has shown.
Stephen Padilla, 31 Aug 2018
Treatment with rivaroxaban results in less recurrent venous thromboembolism (VTE) in frail patients with VTE, with similar good bleeding outcomes, compared with warfarin, reports a study.
Stephen Padilla, 11 Sep 2018
Use of diclofenac, a traditional nonsteroidal anti-inflammatory drug (NSAID) with cyclo-oxygenase-2 (COX-2) selectivity similar to COX-2 inhibitors, is associated with higher cardiovascular health risk compared with nonuse, paracetamol use and use of other traditional NSAIDs, a recent study has shown.