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