Original New Drug Application Approvals by US FDA (16 - 30 June 2020)

30 Jun 2020
Original New Drug Application Approvals by US FDA (16 - 30 June 2020)
New drug applications approved by US FDA as of 16 - 30 June 2020 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.

TAZVERIK
  • Active Ingredient(s): Tazemetostat hydrobromide
  • Strength: 200 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Epizyme, Inc.
  • Approval Date: 18 June 2020
  • Submission Classification: Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval
  • Indication(s): Indicated for the treatment of:
    • Adult and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
    • Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test who have received at least 2 prior systemic therapies.
    • Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
  • Approved Label: 18 June 2020 (PDF)

GIMOTI
  • Active Ingredient(s): Metoclopramide
  • Strength: 15 mg
  • Dosage Form(s) / Route(s): Spray; nasal
  • Company: Evoke Pharma, Inc.
  • Approval Date: 19 June 2020
  • Submission Classification: Type 3 - New Dosage Form and Type 4 - New Combination
  • Indication(s): Indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
  • Approved Label: 19 June 2020 (PDF)

FINTEPLA
  • Active Ingredient(s): Fenfluamine
  • Strength: 2.5 mg/mL
  • Dosage Form(s) / Route(s): Solution; oral
  • Company: Zogenix, Inc.
  • Approval Date: 25 June 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.
  • Approved Label: 25 June 2020 (PDF)

MYCAPSSA   
  • Active Ingredient(s): Octreotide   
  • Strength: 20 mg   
  • Dosage Form(s) / Route(s): Capsule, delayed release; oral   
  • Company: Chiasma, Inc.   
  • Approval Date: 26 June 2020   
  • Submission Classification: Type 5 - New Formulation or New Manufacturer   
  • Indication(s): Not available
  • Approved Label: Not available

PHESGO   
  • Active Ingredient(s): Pertuzumab; trastuzumab; hyaluronidase-zzxf   
  • Strength: 1,200 mg; 600 mg; 30,000 units   
  • Dosage Form(s) / Route(s): Injectable; intravenous, subcutaneous   
  • Company: Genentech, Inc.   
  • Approval Date: 29 June 2020   
  • Submission Classification: Not available   
  • Indication(s): Not available
  • Approved Label: Not available 

NITROGEN, NF
  • Active Ingredient(s): Nitrogen   
  • Strength: Not available   
  • Dosage Form(s) / Route(s): Gas; inhalation   
  • Company: Air Liquide Canada, Inc.   
  • Approval Date: 29 June 2020   
  • Submission Classification: Not available   
  • Indication(s): Not available   
  • Approved Label: Not available
DOJOLVI   
  • Active Ingredient(s): Triheptanoin   
  • Strength: 35%   
  • Dosage Form(s) / Route(s): Liquid; oral   
  • Company: Ultragenyx Pharm, Inc.   
  • Approval Date: 30 June 2020   
  • Submission Classification: Type 1 - New Molecular Entity  
  • Indication(s): Indicated as a source of calories and fatty acids for the treatment of pediatric and adult patients with molecularly confirmed long-chain fatty acid oxidation disorders (LC-FAOD).
  • Approved Label: 30 June 2020 (PDF)