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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
Pearl Toh, 22 Oct 2020
The combination therapy comprising carfilzomib, cyclophosphamide and dexamethasone (KCd) is effective, with a tolerable safety profile, in an Asian cohort with high-risk multiple myeloma (MM) — thus providing a more economical alternative as a potential upfront regimen in resource-limited settings, according to leading experts during a myeloma education webinar.
Pearl Toh, 21 Sep 2020
Early and sustained treatments with simplified regimen are the key to achieving good asthma control, said experts during a presentation at the ERS 2020 Congress.
4 days ago
Weight suppression appears to result in future onset of eating disorders characterized by dietary restriction or compensatory weight control behaviours, suggesting weight-suppressed women represent an at-risk group that may benefit from selective prevention programmes, a study has found.
5 days ago
Nocturia is a risk factor for mortality, according to the results of the Nagahama Study, which boasts of a low incidence of missing data and high representation of the general population.