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 (16 - 31 March 2019)

02 Apr 2019
New drug applications approved by US FDA as of 16 - 31 March 2019 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.

ZYKADIA
  • Active Ingredient(s): Ceritinib
  • Strength:150 mg
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Novartis Pharms Corp
  • Approval Date: 18 Mar 2019
  • Submission Classification: Not Available
  • Indication(s): Indicated for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
  • Approved Label: 18 Mar 2019 (PDF)

ZULRESSO
  • Active Ingredient(s): Brexanolone
  • Strength: 5 mg/mL
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Sage Therapeutics
  • Approval Date: 19 Mar 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of postpartum depression (PPD) in adults.
  • Approved Label: 19 Mar 2019 (PDF)

MAYZENT
  • Active Ingredient(s): Siponimod
  • Strength: 0.25 mg; 2 mg
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Novartis Pharms Corp
  • Approval Date:  26 Mar 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
  • Approved Label26 Mar 2019 (PDF)

JATENZO
  • Active Ingredient(s): Testosterone undecanoate
  • Strength: 237 mg
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Clarus Therapeutics Inc
  • Approval Date: 27 Mar 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
  • Approved Label27 Mar 2019 (PDF)

DUAKLIR PRESSAIR
  • Active Ingredient(s): Aclidinium bromide; formoterol fumarate dihydrate
  • Strength: 400 mcg / 12 mcg
  • Dosage Form(s) / Route(s): Powder; Inhalation
  • Company: AstraZeneca Pharms
  • Approval Date: 29 Mar 2019
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD)
  • Approved Label29 Mar 2019 (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.