Most Read Articles
Stephen Padilla, 6 days ago
Early administration of recombinant human B-type natriuretic peptide (rhBNP) can lower the incidence of reperfusion injury for patients with ST-elevation myocardial infarction (STEMI) who are receiving percutaneous coronary intervention (PCI) treatment, according to a China study.
11 Aug 2019
Intraoperative methylprednisolone does not appear to significantly prevent the incidence of death, cardiac arrest and other injuries in neonates undergoing cardiac surgery with cardiopulmonary bypass, according to a recent study.
2 days ago
Pulmonary function has potential predictive value for future increases in arterial stiffness and its progression, as reported in a recent study.
Yesterday
Systolic blood pressure appears to have a strong association with aneurysmal subarachnoid haemorrhage (aSAH) but not with unruptured intracranial aneurysm (UIA), whereas current smoking and female sex are risk factors for both conditions, a study has found.

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
Stephen Padilla, 6 days ago
Early administration of recombinant human B-type natriuretic peptide (rhBNP) can lower the incidence of reperfusion injury for patients with ST-elevation myocardial infarction (STEMI) who are receiving percutaneous coronary intervention (PCI) treatment, according to a China study.
11 Aug 2019
Intraoperative methylprednisolone does not appear to significantly prevent the incidence of death, cardiac arrest and other injuries in neonates undergoing cardiac surgery with cardiopulmonary bypass, according to a recent study.
2 days ago
Pulmonary function has potential predictive value for future increases in arterial stiffness and its progression, as reported in a recent study.
Yesterday
Systolic blood pressure appears to have a strong association with aneurysmal subarachnoid haemorrhage (aSAH) but not with unruptured intracranial aneurysm (UIA), whereas current smoking and female sex are risk factors for both conditions, a study has found.