Original New Drug Application Approvals by US FDA (01 - 15 September 2020)

15 Sep 2020
Original New Drug Application Approvals by US FDA (01 - 15 September 2020)
New drug applications approved by US FDA as of 01 - 15 September 2020 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.

QDOLO
  • Active Ingredient(s): Tramadol hydrochloride
  • Strength: 5 mg/mL
  • Dosage Form(s) / Route(s): Solution; oral
  • Company: Athena Bioscience LLC
  • Approval Date: 01 September 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Not available
  • Approved Label: Not available

ONUREG
  • Active Ingredient(s): Azacitidine
  • Strength: 200 mg; 300 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Celgene Corp.
  • Approval Date: 01 September 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.
  • Approved Label: 01 September 2020 (PDF)

DETECTNET
  • Active Ingredient(s): Copper Cu 64 dotatate
  • Strength: 148 MBq (4 mCi) (37 MBq (1 mCi) per 1 mL)
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Radiomedix, Inc.
  • Approval Date: 03 September 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Not available
  • Approved Label: Not available

GAVRETO
  • Active Ingredient(s): Pralsetinib
  • Strength: 100 mg
  • Dosage Form(s) / Route(s): Capsule; oral
  • Company: Blueprint Medicines
  • Approval Date: 04 September 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.
  • Approved Label: 04 September 2020 (PDF)