Most Read Articles
Dr. Joseph Delano Fule Robles, 18 Apr 2019

A recent study by investigators from Hong Kong showed that poor sleep quality and longer sleep onset latency are associated with an increased risk of peptic ulcer disease (PUD) recurrence. Depression is also shown to be associated with subsequent incidence of PUD.

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
Dr. Joseph Delano Fule Robles, 18 Apr 2019

A recent study by investigators from Hong Kong showed that poor sleep quality and longer sleep onset latency are associated with an increased risk of peptic ulcer disease (PUD) recurrence. Depression is also shown to be associated with subsequent incidence of PUD.