Original New Drug Application Approvals by US FDA (01 - 15 May 2020)

15 May 2020
New drug applications approved by US FDA as of 01 - 15 May 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.

FENSOLVI
  • Active Ingredient(s): Leuprolide acetate
  • Strength: 45 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Tolmar
  • Approval Date: 01 May 2020
  • Submission Classification: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
  • Indication(s): Indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty.
  • Approved Label01 May 2020 (PDF)

DARZALEX FASPRO
  • Active Ingredient(s): Daratumumab; hyaluronidase-fihj
  • Strength: 120 mg; 2,000 units/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Janssen Biotech
  • Approval Date: 01 May 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of adult patients with multiple myeloma:
    • in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant 
    • in combination with lenalidomide and dexamethasone in newly diagnosed patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
    • in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy
    • as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
  • Approved Label01 May 2020 (PDF)

ELYXYB
  • Active Ingredient(s): Celecoxib
  • Strength: 120 mg/4.8 mL (25 mg/mL)
  • Dosage Form(s) / Route(s): Solution; oral
  • Company: Dr Reddys Labs, Ltd.
  • Approval Date: 05 May 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the acute treatment of migraine with or without aura in adults.
  • Approved Label05 May 2020 (PDF)

TABRECTA
  • Active Ingredient(s): Capmatinib
  • Strength: 150 mg; 200 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Novartis Pharms Corp
  • Approval Date: 06 May 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
  • Approved Label06 May 2020 (PDF)

RETEVMO
  • Active Ingredient(s): Selpeercatinib
  • Strength: 40 mg; 80 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Loxo Oncology, Inc.
  • Approval Date: 08 May 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of:
    • Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC)
    • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullarly thyroid cancer (MCT) who require systemic therapy
    • Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemuc therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)
  • Approved Label08 May 2020 (PDF)

QINLOCK
  • Active Ingredient(s): Ripretinib
  • Strength: 150 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Deciphera Pharmaceuticals LLC
  • Approval Date: 15 May 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
  • Approved Label15 May 2020 (PDF)
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