Most Read Articles
Roshini Claire Anthony, 13 Nov 2020

Diabetes is a key risk factor for heart failure (HF), which is the leading cause of hospitalization in patients with or without diabetes. SGLT-2* inhibitors (SGLT-2is) have been shown to reduce the risk of hospitalization for HF (HHF) regardless of the presence or absence of diabetes.

5 days ago
Vitamin D deficiency may be a contributing factor to the mortality rate among patients with the novel coronavirus disease (COVID-19), reports a new study.
Pearl Toh, 4 days ago
Inhaled corticosteroid (ICS) should be the mainstay of long-term asthma management — such is the key message of the latest Singapore ACE* Clinical Guidance (ACG) for asthma, released in October 2020.
17 Nov 2020
Invasive fungal infections, particularly those caused by Candida species, are common in hospitalized, immunocompromised, or critically ill patients and are associated with considerable morbidity and mortality.

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
Roshini Claire Anthony, 13 Nov 2020

Diabetes is a key risk factor for heart failure (HF), which is the leading cause of hospitalization in patients with or without diabetes. SGLT-2* inhibitors (SGLT-2is) have been shown to reduce the risk of hospitalization for HF (HHF) regardless of the presence or absence of diabetes.

5 days ago
Vitamin D deficiency may be a contributing factor to the mortality rate among patients with the novel coronavirus disease (COVID-19), reports a new study.
Pearl Toh, 4 days ago
Inhaled corticosteroid (ICS) should be the mainstay of long-term asthma management — such is the key message of the latest Singapore ACE* Clinical Guidance (ACG) for asthma, released in October 2020.
17 Nov 2020
Invasive fungal infections, particularly those caused by Candida species, are common in hospitalized, immunocompromised, or critically ill patients and are associated with considerable morbidity and mortality.