Most Read Articles
25 Apr 2019
There is a high incidence of candidaemia and a substantial burden of comorbidities among neonates as confirmed in a recent nationwide epidemiologic study of paediatric candidaemia. An increasing proportion of nonalbicans species resistant to fluconazole has also been observed.
Dr. Joseph Delano Fule Robles, 29 Mar 2019

A study done in Sweden suggests that foetal exposure to maternal infections may increase the risk of autism and depression in the offspring.

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
25 Apr 2019
There is a high incidence of candidaemia and a substantial burden of comorbidities among neonates as confirmed in a recent nationwide epidemiologic study of paediatric candidaemia. An increasing proportion of nonalbicans species resistant to fluconazole has also been observed.
Dr. Joseph Delano Fule Robles, 29 Mar 2019

A study done in Sweden suggests that foetal exposure to maternal infections may increase the risk of autism and depression in the offspring.