Most Read Articles
Christina Lau, 14 Oct 2019

Denosumab can be of benefit to patients with unresectable giant cell tumour of bone (GCTB) and those who are likely to experience significant morbidity after surgical resection of GCTB.

Original New Drug Application Approvals by US FDA (1 - 15 December 2017)

15 Dec 2017

New drug applications approved by US FDA as of 1-15 December 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.

OGIVRI

  • Active Ingredient(s): Transtuzumab-DKST 
  • Strength: 420 mg/vial
  • Dosage Form: Injectable;injection
  • Company: Mylan GMBH
  • Approval Date: December  01, 2017
  • Submission Classification: Not Available
  • Indication(s): Indicated for:
    • The treatment of HER2-overexpressing breast cancer.
    • The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.
  • Approved Label: 12/01/2017(PDF)
LONHALA MAGNAIR
  • Active Ingredient(s):Gycopyrrolate
  • Strength: 25 mcg
  • Dosage Form: Solution;inhalation
  • Company: Sunovion
  • Approval Date: December 05, 2017
  • Submission Classification: Type 3 - New Dosage Form and Type 4 - New Combination
  • Indication(s): Indicated for  the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)
  • Approved Label: 12/05/2017(PDF)
OZEMPIC
  • Active Ingredient(s): Semaglutide
  • Strength: 1.34 mg/ml
  • Dosage Form: Injectable;injection
  • Company: Novo Nordisk Inc
  • Approval Date: December 05, 2017
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated  as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
  • Approved Label: 12/05/2017(PDF)
SINUVA
  • Active Ingredient(s): Mometasone Furoate
  • Strength: 1350 mcg
  • Dosage Form: Implant;sinus
  • Company: Intersect ENT Inc
  • Approval Date: December 08, 2017
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for  the treatment of nasal polyps in patients ≥ 18 years of age who have had ethmoid sinus surgery
  • Approved Label: 12/08/2017(PDF)
XEPI
  • Active Ingredient(s): Ozenoxacin
  • Strength: 1%
  • Dosage Form: Cream;topical
  • Company: Ferrer Internacional S.A.
  • Approval Date: December 11, 2017
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for r the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients 2 months of age and older
  • Approved Label: 12/11/2017(PDF)
ADMELOG
  • Active Ingredient(s): Insulin Pro
  • Strength: U-100
  • Dosage Form: Injectable;injection
  • Company: Sanofi Aventis US
  • Approval Date: December 11, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not available 
  • Approved Label: Not available 
IXIFI
  • Active Ingredient(s): Infliximab-QBTX
  • Strength: 100 mg/vial
  • Dosage Form: Injectable;injection
  • Company: Pfizer Inc
  • Approval Date: December 13, 2017
  • Submission Classification: Not available
  • Indication(s): Indicated for Crohn’s Disease:
    • reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. 
    • reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease.
  • Approved Label: 12/13/2017(PDF)
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Most Read Articles
Christina Lau, 14 Oct 2019

Denosumab can be of benefit to patients with unresectable giant cell tumour of bone (GCTB) and those who are likely to experience significant morbidity after surgical resection of GCTB.