Original New Drug Application Approvals by US FDA (1-15 June 2024)

21 Jun 2024
Original New Drug Application Approvals by US FDA (1-15 June 2024)
New drug applications approved by US FDA as of 1-15 June 2024 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.

TERIPARATIDE
  • Active Ingredient(s): Teriparatide
  • Strength: 0.6MG/2.4ML (0.25MG/ML)
  • Dosage Form(s) / Route(s): Solution;subcutaneous
  • Company: Almaject
  • Approval Date: 4 June 2024
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for:
    • Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy
    • Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy
    • Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy
  • Approved Label:  4 June 2024 (PDF)
RYTELO
  • Active Ingredient(s): Imetelstat Sodium
  • Strength: EQ 47MG BASE/VIAL, EQ 188MG BASE/VIAL 
  • Dosage Form(s) / Route(s): Powder;intravenous
  • Company: Geron
  • Approval Date: 6 June 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with low-to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).
  • Approved Label:  6 June 2024 (PDF)
IQIRVO
  • Active Ingredient(s): Elafibranor
  • Strength: 80MG
  • Dosage Form(s) / Route(s): Tablet;oral
  • Company: Ipsen Biopharm Ltd
  • Approval Date: 10 June 2024
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.
    This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
    • Limitations of Use
    Use of IQIRVO is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).
  • Approved Label:  10 June 2024 (PDF)