Most Read Articles
30 Apr 2018
Adolescents appear to have disordered normal brain growth trajectories after initiating drinking, with or without co-use of marijuana, a recent study has found. Peak consumption in the past year and family history of alcoholism possibly contribute to abnormal cortical volume trajectories.

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

31 Dec 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.

RUBRACA
  • 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)

SPINRAZA
  • 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)

COLPREP KIT
  • Active Ingredient(s): SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE
  • 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)

CASPOFUNGIN ACETATE
  • 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)
Editor's Recommendations
Most Read Articles
30 Apr 2018
Adolescents appear to have disordered normal brain growth trajectories after initiating drinking, with or without co-use of marijuana, a recent study has found. Peak consumption in the past year and family history of alcoholism possibly contribute to abnormal cortical volume trajectories.