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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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