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

15 Sep 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 Label01 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 Label04 September 2020 (PDF)
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Most Read Articles
2 days ago
Chest pain appears to be the principal complaint of patients hospitalized with a first myocardial infarction (MI), particularly among those in the youngest age group, a study has found.
Jairia Dela Cruz, 16 Sep 2020
In patients with heart failure with reduced ejection fraction (HFrEF) receiving angiotensin-converting-enzyme (ACE) inhibitors, high dosing confers benefits for the risk of death or hospitalization that are similar to that obtained with lower dosing, according to a systematic review and meta-analysis.
Pearl Toh, 2 days ago
Early and sustained treatments with simplified regimen are the key to achieving good asthma control, said experts during a presentation at the ERS 2020 Congress.
3 days ago
Women with pre-eclampsia are at higher risk of developing heart failure, a study suggests.