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)