Most Read Articles
23 Nov 2018
Initial acute respiratory illness (ARI) admissions related to human adenovirus (HAdV), human metapneumovirus (hMPV) and human rhinovirus (HRV) occurring during early infancy increase the risk of subsequent ARI-related readmission, a recent study has shown.
Jairia Dela Cruz, 08 Jan 2020
In chronic obstructive pulmonary disease (COPD) patients initiating inhaled corticosteroid (ICS)/long-acting β2 agonist (LABA) combinations, both budesonide/formoterol (FOR) dry-powder inhalers and beclomethasone/FOR metered-dose inhalers pose lower risks of severe pneumonia and severe adverse events compared with fluticasone/salmeterol delivered using the same type of inhaler, as reported in a recent study.
Roshini Claire Anthony, 19 Dec 2019

First-line treatment with the epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) dacomitinib demonstrated persistent survival benefit in patients with EGFR-positive advanced non-small cell lung cancer (NSCLC), according to updated results from the phase III ARCHER 1050* trial.

Pearl Toh, 03 Dec 2018
Sequential treatment with afatinib followed by osimertinib enables prolonged chemotherapy-free treatment while sustaining clinical benefit in patients with EGFR-mutation positive (EGFR+) non-small–cell lung cancer (NSCLC) who acquire T790M mutation, according to the real-world retrospective GioTag study presented at ESMO Asia 2018.

Original New Drug Application Approvals by US FDA (1 - 15 July 2018)

15 Jul 2018

New drug applications approved by US FDA as of 1-15 July 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.

ATROPINE INJECTION, 2 mg/0.7 mL, Single-Dose Autoinjector

  • Active Ingredient(s): Atropine
  • Strength: 2 mg/0.7 ml
  • Dosage Form: Injectable; injection
  • Company: RAFA LABLTD
  • Approval Date: July 09, 2018
  • Submission Classification: Not Applicable
  • Indication(s): Indicated for the treatment of poisoning by susceptible organophosphorous nerve agents having cholinesterase activity as well as organophosphorous or carbamate insecticides in adults and pediatric patients weighing over 90 lbs [41 kg] (generally over 10 years of age). 
  • Approved Label: 07/09/2018(PDF)
VANCOMYCIN HYDROCHLORIDE
  • Active Ingredient(s): Vancomycin Hydrochloride
  • Strength: 250 mg/vial, 750 mg/vial, 1.25 mg/vial, 1.5 mg/vial
  • Dosage Form: Injectable; injection
  • Company: Mylan Labs Ltd
  • Approval Date: July 10, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated n adult and pediatric patients (neonates and older) for the treatment of : 
    • Septicemia
    • Infective Endocarditis 
    • Skin and Skin Structure Infections
    • Bone Infections
    • Lower Respiratory Tract Infections 
  • Approved Label: 07/10/2018(PDF)
GLYRX-PF
  • Active Ingredient(s): Glycopyrrolate
  • Strength: 0.2 mg/ml
  • Dosage Form: Injectable; intramuscular, intravenous
  • Company: Exela Pharma SCS LLC
  • Approval Date: July 11, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in anesthesia (adult and pediatric patients):
    • for reduction of airway or gastric secretions, and volume and acidity of gastric secretions, and blockade of cardiac inhibitory reflexes during induction of anesthesia and intubation.
    • intraoperatively to counteract surgically or drug-induced or vagal reflexassociated arrhythmias.
    • for protection against peripheral muscarinic effects of cholinergic agents.

    Indicated in peptic ulcer (adults)

    • as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or oral medication is not tolerated.
  • Approved Label: 07/11/2018(PDF)
BORTEZOMIB
  • Active Ingredient(s): Bortezomib
  • Strength: 2.5 mg
  • Dosage Form: Injectable; injection
  • Company: Hospira Inc
  • Approval Date: July 12, 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not applicable
  • Approved Label: Not applicable
TPOXX
  • Active Ingredient(s): Tecovirimat
  • Strength: 200 mg
  • Dosage Form: Capsule; oral
  • Company: Siga Technologies Inc
  • Approval Date: July 13, 2018
  • Submission Classification: Not applicable
  • Indication(s): Indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 13 kg.
  • Approved Label: 07/13/2018(PDF)
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Most Read Articles
23 Nov 2018
Initial acute respiratory illness (ARI) admissions related to human adenovirus (HAdV), human metapneumovirus (hMPV) and human rhinovirus (HRV) occurring during early infancy increase the risk of subsequent ARI-related readmission, a recent study has shown.
Jairia Dela Cruz, 08 Jan 2020
In chronic obstructive pulmonary disease (COPD) patients initiating inhaled corticosteroid (ICS)/long-acting β2 agonist (LABA) combinations, both budesonide/formoterol (FOR) dry-powder inhalers and beclomethasone/FOR metered-dose inhalers pose lower risks of severe pneumonia and severe adverse events compared with fluticasone/salmeterol delivered using the same type of inhaler, as reported in a recent study.
Roshini Claire Anthony, 19 Dec 2019

First-line treatment with the epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) dacomitinib demonstrated persistent survival benefit in patients with EGFR-positive advanced non-small cell lung cancer (NSCLC), according to updated results from the phase III ARCHER 1050* trial.

Pearl Toh, 03 Dec 2018
Sequential treatment with afatinib followed by osimertinib enables prolonged chemotherapy-free treatment while sustaining clinical benefit in patients with EGFR-mutation positive (EGFR+) non-small–cell lung cancer (NSCLC) who acquire T790M mutation, according to the real-world retrospective GioTag study presented at ESMO Asia 2018.