Most Read Articles
Stephen Padilla, 5 days ago
The Mandarin-speaking population in Singapore (SG) has deemed the translated Chronic Liver Disease Questionnaire (CLDQ) culturally acceptable, with only two items that needed revision in the finalized CLDQ-SG, according to a recent study.

Original New Drug Application Approvals by US FDA (01- 15 December 2018)

15 Dec 2018
New drug applications approved by US FDA as of 01- 15 December 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.

TOLSURA
  • Active Ingredient(s): Itraconazole
  • Strength: 65 MG
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Mayne Pharma Inc
  • Approval Date: 11 Dec 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised adult patients:
    • Blastomycosis, pulmonary and extrapulmonary
    • Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and
    • Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy.
  • Approved Label: 11 Dec 2018 (PDF)

MOTEGRITY
  • Active Ingredient(s): Prucalopride
  • Strength: 1MG; 2MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Shire Dev LLC
  • Approval Date: 14 Dec 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of chronic idiopathic constipation (CIC) in adults
  • Approved Label: 14 Dec 2018 (PDF)

HERZUMA
  • Active Ingredient(s): Trastuzumab-pkrb
  • Strength: 420MG
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Celltrion Inc
  • Approval Date: 14 Dec 2018
  • Submission Classification: Not Available
  • Indication(s): Indicated for the treatment of HER2-overexpressing breast cancer.
  • Approved Label: 14 Dec 2018 (PDF)
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Most Read Articles
Stephen Padilla, 5 days ago
The Mandarin-speaking population in Singapore (SG) has deemed the translated Chronic Liver Disease Questionnaire (CLDQ) culturally acceptable, with only two items that needed revision in the finalized CLDQ-SG, according to a recent study.