Most Read Articles
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.
11 Aug 2019
Treatment with low-to-standard dose dual combination therapy of blood pressure (BP)-lowering drugs is more effective than standard-dose monotherapy and does not increase withdrawals due to adverse events, a recent study has shown.
20 Jun 2019
Untreated white coat hypertension (WCH), but not treated white coat effect (WCE), may increase the risk for cardiovascular events and all-cause mortality, suggest the results of a systematic review and meta-analysis. Out-of-office blood pressure (BP) monitoring is thus important in the diagnosis and management of hypertension.
06 Aug 2019
Risk factors for 1-year mortality in heart failure (HF) patients significantly differ between those with and without chronic kidney disease (CKD), especially with regard to the use of beta-blockers or diuretics at discharge, according to a study. This suggests that these patients may benefit from individualized therapies.

Original New Drug Application Approvals by US FDA (01 - 15 July 2019)

15 Jul 2019
New drug applications approved by US FDA as of 01 - 15 July 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.

XPOVIO
  • Active Ingredient(s): Selinexor
  • Strength: 20 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Karyopharm Therapeutics Inc.
  • Approval Date: 03 July 2019
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
  • Approved Label03 July 2019 (PDF)

KATERZIA
  • Active Ingredient(s): Amlodipine benzoate
  • Strength: 1 mg/mL
  • Dosage Form(s) / Route(s): Suspension; oral
  • Company: Silvergate Pharms
  • Approval Date: 08 July 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): May be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:
    • Hypertension: indicated for the treatment of hypertension in adults and children 6 years and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily stroke and myocardial infarctions.
    • Coronary Artery Disease: Chronic Stable Angina; Vasospastic Angina (Prinzmetal's or Variant Angina); Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction <40%.
  • Approved Label08 July 2019 (PDF)
Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Cardiology - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
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.
11 Aug 2019
Treatment with low-to-standard dose dual combination therapy of blood pressure (BP)-lowering drugs is more effective than standard-dose monotherapy and does not increase withdrawals due to adverse events, a recent study has shown.
20 Jun 2019
Untreated white coat hypertension (WCH), but not treated white coat effect (WCE), may increase the risk for cardiovascular events and all-cause mortality, suggest the results of a systematic review and meta-analysis. Out-of-office blood pressure (BP) monitoring is thus important in the diagnosis and management of hypertension.
06 Aug 2019
Risk factors for 1-year mortality in heart failure (HF) patients significantly differ between those with and without chronic kidney disease (CKD), especially with regard to the use of beta-blockers or diuretics at discharge, according to a study. This suggests that these patients may benefit from individualized therapies.