Most Read Articles
2 days ago
New drug applications approved by US FDA as of 01 - 15 November 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. 
3 days ago
Streptococcus anginosus, aminoglycoside-susceptible Gram-negative bacilli and anaerobes remain the most common bacteria in previously healthy children presenting with complicated appendicitis requiring surgical drainage, reports a 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
2 days ago
New drug applications approved by US FDA as of 01 - 15 November 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. 
3 days ago
Streptococcus anginosus, aminoglycoside-susceptible Gram-negative bacilli and anaerobes remain the most common bacteria in previously healthy children presenting with complicated appendicitis requiring surgical drainage, reports a study.