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 April 2019)

16 Apr 2019
New drug applications approved by US FDA as of 01 - 15 April 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.

WELCHOL
  • Active Ingredient(s): Colesevelam hydrochloride
  • Strength: 3.75 g
  • Dosage Form(s) / Route(s): Bar, chewable; Oral
  • Company: Daiichi Sankyo Inc.
  • Approval Date: 03 Apr 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated as an adjunct to diet and exercise to: 
    • reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia
    • reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH)
    • improve glycemic control in adults with type 2 diabetes mellitus
  • Approved Label: 03 Apr 2019 (PDF)

DOLUTEGRAVIR; LAMIVUDINE
  • Active Ingredient(s): Dolutegravir and lamivudine
  • Strength: 50 mg; 300 mg
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: ViiV Healthcare
  • Approval Date: 08 Apr 2019
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with no antiretroviral treatment history and with no known substitutions associated with resistance to the individual components of DOVATO
  • Approved Label08 Apr 2019 (PDF)

EVENITY
  • Active Ingredient(s): Romosozumab-aqqg
  • Strength: 105 mg/1.17 mL
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Amgen Inc.
  • Approval Date: 09 Apr 2019
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy
  • Approved Label09 Apr 2019 (PDF)

LEVOTHYROXINE SODIUM
  • Active Ingredient(s): Levothyroxine sodium
  • Strength: 100 mcg; 200 mcg; 500 mcg
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Fresenius Kabi USA
  • Approval Date: 11 Apr 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated in adult patients for the treatment of myxedema coma
  • Approved Label11 Apr 2019 (PDF)

BALVERSA
  • Active Ingredient(s): Erdafitinib
  • Strength: 3 mg; 4 mg; 5 mg
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Janssen Biotech
  • Approval Date: 12 Apr 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma that has:
    • susceptible FGFR3 or FGFR2 genetic alterations and
    • progressed during or following at least one line of prior platinum-containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
  • Approved Label11 Apr 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.