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

16 Oct 2017
Original New Drug Application Approvals by US FDA (1- 15 October 2017)
New drug applications approved by US FDA as of 1 - 15 October 2017 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.

ASCOR
  • Active Ingredient(s): ASCORBIC ACID
  • Strength: 500MG/ML
  • Dosage Form: Injectable;Injection
  • Company: Mcguff Pharmaceuticals Inc
  • Approval Date: October 2, 2017
  • Submission Classification: Type 7 - Drug Already Marketed without Approved NDA
  • Indication(s): Indicated for the short term (up to 1 week) treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated
  • Approved Label: 10/02/2017 (PDF)

ZILRETTA
  • Active Ingredient(s): TRIAMCINOLONE ACETONIDE
  • Strength: 32MG
  • Dosage Form: Intramuscular extended-release injectable suspension
  • Company: Flexion Therapeutics Inc
  • Approval Date: October 6, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated as an intra-articular injection for the management of osteoarthritis pain of the knee
  • Approved Label: 10/06/2017 (PDF)

LYRICA CR
  • Active Ingredient(s): PREGABALIN
  • Strength: 82.5MG | 165MG | 330MG
  • Dosage Form: Extended release oral tablet
  • Company: Pfizer Inc
  • Approval Date: October 11, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the management of:
    • Neuropathic pain associated with diabetic peripheral neuropathy (DPN)
    • Postherpetic neuralgia (PHN)
  • Approved Label: 10/11/2017 (PDF)

FOSAPREPITANT
  • Active Ingredient(s): FOSAPREPITANT
  • Strength: 150MG/VIAL
  • Dosage Form: Injectable;Injection
  • Company: Teva Pharms USA Inc
  • Approval Date: October 12, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the prevention of:
    • Acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin
    • Delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC)
  • Approved Label: Not available
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