Original New Drug Application Approvals by US FDA (01 - 15 June 2022)

15 Jun 2022
Original New Drug Application Approvals by US FDA (01 - 15 June 2022)
New drug applications approved by US FDA as of 01 - 15 June 2022 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.

TESTOSTERONE CYPIONATE
  • Active Ingredient(s): Testosterone Cypionate
  • Strength: 200MG/ML
  • Dosage Form(s) / Route(s): Solution;Intramuscular
  • Company: Slayback Pharma Llc
  • Approval Date: 02 June 2022
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone.
  • Approved Label:  02 June 2022 (PDF)
ACETAMINOPHEN
  • Active Ingredient(s): Acetaminophen
  • Strength: 1,000MG/100ML(10MG/ML)
  • Dosage Form(s) / Route(s): Solution;Intramuscular
  • Company: Innopharma
  • Approval Date: 03 June 2022
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): 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:  03 June 2022 (PDF)
AMVUTTRA
  • Active Ingredient(s): Vutrisiran
  • Strength: 25MG
  • Dosage Form(s) / Route(s): Injectable;Subcutaneous
  • Company: Alnylam Pharms Inc
  • Approval Date: 13 June 2022
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults.
  • Approved Label:  13 June 2022 (PDF)