Most Read Articles
12 Apr 2019
Long-acting beta2-agonist (LABA) plus long-acting muscarinic antagonist (LAMA) combinations compare with inhalers containing both LABA and corticosteroid (LABA-ICS) in terms of reducing chronic obstructive pulmonary disease (COPD) exacerbations, although the LAMA-LABA combination is more favourable as it is associated with fewer episodes of severe pneumonia, according to a study.
16 Jan 2017
There are various ear, nose, and throat (ENT) conditions which present to the GP’s clinic. Dr Jason Hwang, an ENT Consultant from the Department of Otolaryngology at Gleneagles Hospital in Singapore, speaks on how the majority of the conditions can be effectively managed at the primary care level seeing that these can be treated medically without the need for surgical intervention.
12 Mar 2019
The use of magnesium supplements as an adjunct to standard asthma treatment in patients with mild-to-moderate disease confers no significant benefits apart from an improvement in forced expiratory volume in 1 second after 8 weeks of treatment, according to the results of a meta-analysis.

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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Editor's Recommendations
Most Read Articles
12 Apr 2019
Long-acting beta2-agonist (LABA) plus long-acting muscarinic antagonist (LAMA) combinations compare with inhalers containing both LABA and corticosteroid (LABA-ICS) in terms of reducing chronic obstructive pulmonary disease (COPD) exacerbations, although the LAMA-LABA combination is more favourable as it is associated with fewer episodes of severe pneumonia, according to a study.
16 Jan 2017
There are various ear, nose, and throat (ENT) conditions which present to the GP’s clinic. Dr Jason Hwang, an ENT Consultant from the Department of Otolaryngology at Gleneagles Hospital in Singapore, speaks on how the majority of the conditions can be effectively managed at the primary care level seeing that these can be treated medically without the need for surgical intervention.
12 Mar 2019
The use of magnesium supplements as an adjunct to standard asthma treatment in patients with mild-to-moderate disease confers no significant benefits apart from an improvement in forced expiratory volume in 1 second after 8 weeks of treatment, according to the results of a meta-analysis.