Original New Drug Application Approvals by US FDA (16 - 28 February 2021)

02 Mar 2021
New drug applications approved by US FDA as of 16-28 February 2021 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.

ACETAMINOPHEN
  • Active Ingredient(s): Acetaminophen
  • Strength: 1GM/100ML (10MG/ML) ; 500MG/50ML (10MG/ML)
  • Dosage Form(s) / Route(s): Solution; Intravenous
  • Company: B Braun Medical Inc
  • Approval Date: 18 Feb 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Acetaminophen Injection is indicated for the:
    • Management of mild to moderate pain in adult and pediatric patients 2 years and older
    • Management of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older
    • Reduction of fever in adult and pediatric patients
  • Approved Label:  18 Feb 2021 (PDF)
PEMETREXED
  • Active Ingredient(s): Pemetrexed
  • Strength: 100MG/4ML(25MG/ML) ;500MG/20ML(25MG/ML) ; 1G/40ML(25MG/ML)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Hospira Inc
  • Approval Date: 23 Feb 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not Available
  • Approved Label: Not Available
AMONDYS 45
  • Active Ingredient(s): Casimersen
  • Strength: 100 mg/2 mL/VIAL
  • Dosage Form(s) / Route(s): Solution; Intravenous
  • Company: Sarepta Theraps Inc
  • Approval Date: 25 Feb 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping.
  • Approved Label: 25 Feb 2021 (PDF)
NULIBRY
  • Active Ingredient(s): Fosdenopterin
  • Strength: 9.5MG
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Origin Biosciences Inc
  • Approval Date: 26 Feb 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Not Available
  • Approved Label: Not Available
PEPAXTO
  • Active Ingredient(s): Melphalan Flufenamide
  • Strength: 20MG
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Oncopeptides AB
  • Approval Date: 26 Feb 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): indicated in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody
  • Approved Label: 26 Feb 2021 (PDF)
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