Most Read Articles
Roshini Claire Anthony, 12 Jun 2019

Women with platinum-sensitive ovarian cancer with germline BRCA mutations who relapsed after previously receiving 2 lines of chemotherapy demonstrated better objective response rates (ORRs) and progression-free survival (PFS) following treatment with olaparib than platinum-based chemotherapy, according to results of the SOLO3* trial.

Original New Drug Application Approvals by US FDA (16 - 30 November 2016)

30 Nov 2016
New drug applications approved by US FDA as of 16 - 30 November 2016 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.

INTRAROSA
  • Active Ingredient(s): PRASTERONE
  • Strength: 6.5MG
  • Dosage Form: Vaginal insert
  • Company: Endoceutics Inc
  • Approval Date: November 16, 2016
  • Chemical Type: Type 2 New Active Ingredient and Type 4 New Combination
  • Indication(s): Indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause
  • Approved Label: 11/16/2016 (PDF)

XULTOPHY
  • Active Ingredient(s): INSULIN DEGLUDEC;LIRAGLUTIDE
  • Strength: 100;3.6
  • Dosage Form: Injectable;injection
  • Company: Novo Nordisk Inc
  • Approval Date: November 21, 2016
  • Chemical Type: Type 4 - New Combination
  • Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 50 units daily) or liraglutide (less than or equal to 1.8 mg daily)
  • Approved Label: 11/21/2016 (PDF)

SOLIQUA
  • Active Ingredient(s): INSULIN GLARGINE;LIXISENATIDE
  • Strength: 100UNITS;50MCG
  • Dosage Form: Injectable; injection
  • Company: Sanofi Aventis US
  • Approval Date: November 21, 2016
  • Chemical Type: Not available
  • Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 60 units daily) or lixisenatide
  • Approved Label: 11/21/2016 (PDF)
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Most Read Articles
Roshini Claire Anthony, 12 Jun 2019

Women with platinum-sensitive ovarian cancer with germline BRCA mutations who relapsed after previously receiving 2 lines of chemotherapy demonstrated better objective response rates (ORRs) and progression-free survival (PFS) following treatment with olaparib than platinum-based chemotherapy, according to results of the SOLO3* trial.