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01 Nov 2018
The prevalence of allergic diseases in the Asia-Pacific region is expected to rise over the next 20 years, driven by rapid economic development and urbanization. Allergic diseases have high socioeconomic impact by impairing productivity and quality of life, and the impact may be greater in Asia-Pacific than in Europe due to the presence and predominance of perennial allergens.

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 Nov 2018
The prevalence of allergic diseases in the Asia-Pacific region is expected to rise over the next 20 years, driven by rapid economic development and urbanization. Allergic diseases have high socioeconomic impact by impairing productivity and quality of life, and the impact may be greater in Asia-Pacific than in Europe due to the presence and predominance of perennial allergens.