Most Read Articles
Pearl Toh, 21 Sep 2020
Early and sustained treatments with simplified regimen are the key to achieving good asthma control, said experts during a presentation at the ERS 2020 Congress.
Roshini Claire Anthony, 22 Sep 2020

Treatment with the DPP 1* inhibitor brensocatib prolonged time to exacerbation and reduced exacerbation rates in patients with non-cystic fibrosis bronchiectasis, according to the phase II WILLOW** study presented at ERS 2020.

Audrey Abella, 22 Sep 2020
The first-in-class oral tyrosine kinase inhibitor (TKI) masitinib demonstrated a positive benefit-risk profile over a sustained period in patients with severe persistent asthma regardless of baseline eosinophil level, with the greatest benefit seen among those with the highest oral corticosteroid (OCS) dependency, according to data presented at ERS 2020.
Audrey Abella, 05 Oct 2020
Regular, low-dose, oral sustained-release morphine improved the health status of patients with moderate-to-very-severe chronic breathlessness due to chronic obstructive pulmonary disease (COPD), the MORDYC* trial has shown, validating its palliative role for chronic breathlessness.

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
Pearl Toh, 21 Sep 2020
Early and sustained treatments with simplified regimen are the key to achieving good asthma control, said experts during a presentation at the ERS 2020 Congress.
Roshini Claire Anthony, 22 Sep 2020

Treatment with the DPP 1* inhibitor brensocatib prolonged time to exacerbation and reduced exacerbation rates in patients with non-cystic fibrosis bronchiectasis, according to the phase II WILLOW** study presented at ERS 2020.

Audrey Abella, 22 Sep 2020
The first-in-class oral tyrosine kinase inhibitor (TKI) masitinib demonstrated a positive benefit-risk profile over a sustained period in patients with severe persistent asthma regardless of baseline eosinophil level, with the greatest benefit seen among those with the highest oral corticosteroid (OCS) dependency, according to data presented at ERS 2020.
Audrey Abella, 05 Oct 2020
Regular, low-dose, oral sustained-release morphine improved the health status of patients with moderate-to-very-severe chronic breathlessness due to chronic obstructive pulmonary disease (COPD), the MORDYC* trial has shown, validating its palliative role for chronic breathlessness.