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

16 Oct 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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Most Read Articles
Natalia Reoutova, 3 days ago

A retrospective analysis of seven clinical trials demonstrated that neratinib-based therapy is safe and effective in Asian patients with metastatic HER2-positive breast cancer.

Christina Lau, 14 Feb 2019
Progress in the treatment of rare cancers has been named Advance of the Year by the American Society of Clinical Oncology (ASCO).
Pearl Toh, 28 Aug 2019
The addition of radium-223 (Ra223) to enzalutamide for the treatment of mCRPC* was associated with increased fracture risk, which was entirely abolished with mandated use of bone-protecting agents (BPAs) such as zoledronic acid and denosumab, according to interim results of the EORTC 1333 (PEACE III) trial.
Audrey Abella, 28 Aug 2019
A pooled analysis of six trials failed to show noninferiority of a 3-month regimen to a 6-month regimen of oxaliplatin-based chemotherapy for patients with high-risk, stage II colorectal cancer (CRC).