Most Read Articles
02 Aug 2018
At a dinner symposium at Le Méridien Kuala Lumpur, Professor Dato’ Prepageran Narayanan presented the data concerning allergic rhinitis (AR) in Malaysia, and he discussed the role of intranasal corticosteroids (INCSs) in managing AR.
12 Nov 2017
Active and passive smoking are associated with atopic dermatitis, a new study from Korea reveals.
Pearl Toh, 19 Apr 2017
Almost half of secondary school children who had been diagnosed with asthma had suboptimal asthma control, yet over half of those surveyed did not use their inhalers as prescribed, a recent study found.

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
02 Aug 2018
At a dinner symposium at Le Méridien Kuala Lumpur, Professor Dato’ Prepageran Narayanan presented the data concerning allergic rhinitis (AR) in Malaysia, and he discussed the role of intranasal corticosteroids (INCSs) in managing AR.
12 Nov 2017
Active and passive smoking are associated with atopic dermatitis, a new study from Korea reveals.
Pearl Toh, 19 Apr 2017
Almost half of secondary school children who had been diagnosed with asthma had suboptimal asthma control, yet over half of those surveyed did not use their inhalers as prescribed, a recent study found.