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01 Apr 2016
Posaconazole oral suspension may be effective in managing fungal infections among lung transplant recipients, as presented in a single-centre, retrospective study.
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Continuous positive airway pressure (CPAP), a noninvasive ventilation, may help improve respiratory rate and reduce mortality in children with respiratory distress, particularly in those younger than 1 year, a recent study showed. CPAP intervention was initiated by nurses with minimal physician supervision in the study, supporting the use of noninvasive ventilation in low-resource settings where laboratory diagnostic tests are not readily available.

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
01 Apr 2016
Posaconazole oral suspension may be effective in managing fungal infections among lung transplant recipients, as presented in a single-centre, retrospective study.
Saras Ramiya, 19 Nov 2018
Sunway Medical Centre is collaborating with Royal Papworth Hospital to facilitate knowledge exchange among cardiology and respiratory experts.
Tristan Manalac, 11 Sep 2018
The immediate reduction of cigarette nicotine content results in greater improvements in levels of smoke exposure biomarkers than gradual reduction, though withdrawal symptoms are stronger, according to a recent study.
Pearl Toh, 31 Jul 2017
Continuous positive airway pressure (CPAP), a noninvasive ventilation, may help improve respiratory rate and reduce mortality in children with respiratory distress, particularly in those younger than 1 year, a recent study showed. CPAP intervention was initiated by nurses with minimal physician supervision in the study, supporting the use of noninvasive ventilation in low-resource settings where laboratory diagnostic tests are not readily available.