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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
Roshini Claire Anthony, 4 days ago

For coffee drinkers, drinking filtered coffee may be tied to a lower mortality risk, including cardiovascular disease (CVD)-related mortality, a study from Norway suggested.

Stephen Padilla, 5 days ago
Use of noninvasive ventilation (NIV), similar to invasive mechanical ventilation (IMV), appears to lessen mortality but may increase the risk for transmission of the novel coronavirus disease (COVID-19) in healthcare workers, suggest the results of a study.
Yesterday
Use of corticosteroid is not associated with improved outcomes in idiopathic pulmonary fibrosis (IPF) patients admitted to the hospital with acute exacerbation (AE), reveals a recent study. In addition, corticosteroids may even contribute to reduced overall survival following exacerbation.
Dr. Wong Soon Tee, 5 days ago
Acne is a common skin problem seen in primary care. Dr Wong Soon Tee of Assurance Skin Clinic at Mt Elizabeth Novena Hospital, Singapore shares his insights with Pearl Toh on how to manage acne in the primary care setting.