Most Read Articles
Dr. Joseph Delano Fule Robles, 23 Jan 2019

Scientists from the Department of Microbiology, University of Hong Kong (HKU) recently discovered a compound with broad antiviral activity against viruses causing Middle East Respiratory Syndrome (MERS), avian flu (H7N9), severe acute respiratory syndrome (SARS) and Zika fever.

Roshini Claire Anthony, 05 Jul 2016

Renal transplant recipients have a high incidence of hospitalization due to pyelonephritis, according to a Danish population-based cohort study.

Original New Drug Application Approvals by US FDA (01- 15 February 2019)

15 Feb 2019
New drug applications approved by US FDA as of 01- 15 February 2019 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.

JEUVEAU
  • Active Ingredient(s): PrabotulinumtoxinA-xvfs
  • Strength: 100 units
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Evolus Inc.
  • Approval Date: 01 Feb 2019
  • Submission Classification: Not Available
  • Indication(s): Indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients
  • Approved Label: 01 Feb 2019 (PDF)

CABLIVI
  • Active Ingredient(s): Caplacizumab-yhdp
  • Strength: 11 mg/vial
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Ablynx NV
  • Approval Date: 06 Feb 2019
  • Submission Classification: Not Available
  • Indication(s): Indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP),in combination with plasma exchange and immunosuppressive therapy
  • Approved Label: 06 Feb 2019 (PDF)

EGATEN
  • Active Ingredient(s): Triclabendazole
  • Strength: 250 mg
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Novartis Pharms Corp
  • Approval Date: 13 Feb 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of fascioliasis in patients 6 years of age and older.
  • Approved Label: 13 Feb 2019 (PDF)

VANCOMYCIN
  • Active Ingredient(s): Vancomycin
  • Strength: 500mg/100mL; 1g/200mL; 1.5g/300mL
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Xellia Pharms ApS
  • Approval Date: 15 Feb 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in adult and pediatric patients (1 month and older) for the treatment of:  septicemia, infective endocarditis, skin and skin structure infections, bone infections, lower respiratory tract infections.
  • Approved Label: 15 Feb 2019 (PDF)
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Most Read Articles
Dr. Joseph Delano Fule Robles, 23 Jan 2019

Scientists from the Department of Microbiology, University of Hong Kong (HKU) recently discovered a compound with broad antiviral activity against viruses causing Middle East Respiratory Syndrome (MERS), avian flu (H7N9), severe acute respiratory syndrome (SARS) and Zika fever.

Roshini Claire Anthony, 05 Jul 2016

Renal transplant recipients have a high incidence of hospitalization due to pyelonephritis, according to a Danish population-based cohort study.