Original New Drug Application Approvals by US FDA (16 - 31 December 2016)

31 Dec 2016
Original New Drug Application Approvals by US FDA (16 - 31 December 2016)
New drug applications approved by US FDA as of 16 - 31 December 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.

  • Active Ingredient(s): RUCAPARIB
  • Strength: 200MG; 300MG
  • Dosage Form: Oral tablet
  • Company: Clovis Oncology, Inc
  • Approval Date: December 19, 2016
  • Chemical Type: Not available
  • Indication(s): Indicated as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic for RUBRACA
  • Approved Label: 12/19/2016 (PDF)

  • Active Ingredient(s): NUSINERSEN
  • Strength: 2.4MG/ML
  • Dosage Form: Injectable; Injection
  • Company: Biogen
  • Approval Date: December 23, 2016
  • Chemical Type: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients
  • Approved Label: 12/23/2016 (PDF)

  • Strength: 17.5G; 3.13G; 1.6G
  • Dosage Form: Oral Solution
  • Company: Gator Pharma Inc
  • Approval Date: December 27, 2016
  • Chemical Type: Type 3 - New Dosage Form
  • Indication(s): Indicated for cleansing of the colon as a preparation for colonoscopy in adults
  • Approved Label: 12/27/2016 (PDF)

  • Active Ingredient(s): CASPOFUNGIN ACETATE
  • Strength: 50MG; 70MG
  • Dosage Form: Injectable; injection
  • Company: Fresenius Kabi USA
  • Approval Date: December 30, 2016
  • Chemical Type: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in adults and pediatric patients (3 months of age and older) for:
    • Empirical therapy for presumed fungal infections in febrile, neutropenic patients
    • Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections
    • Treatment of esophageal candidiasis
    • Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies
  • Approved Label: 12/30/2016 (PDF)
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