Most Read Articles
05 Nov 2019
Low total cholesterol levels appear to carry increased major adverse cardiovascular events (MACE) hazard in older men without ischaemic heart disease (IHD) and not receiving statin therapy but not to those on statins, according to data from the CHAMP (Concord Health and Ageing in Men Project) cohort.
Tristan Manalac, 25 Aug 2017
Using blunt needles to administer local anaesthesia in upper blepharoplasty has a lower risk of haemorrhage and need for interventional pain procedures compared with sharp needles, a new randomized clinical trial has found.
09 Nov 2019
In patients with acute ST-segment elevation myocardial infarction (ASTEMI), the risk of new-onset atrial fibrillation (NOAF) appears to be linked with plasma levels of low-density lipoprotein cholesterol (LDL-C) and total cholesterol (TC), a recent China study has found.
23 Oct 2019
Implementing a high-sensitivity cardiac troponin I assay with sex-specific diagnostic thresholds results in identifying five times more women than men with myocardial injury, reports a study.

Original New Drug Application Approvals by US FDA (16 - 30 April 2019)

01 May 2019
New drug applications approved by US FDA as of 16 - 30 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.

ELCYS
  • Active Ingredient(s): Cysteine hydrochloride
  • Strength: 50 mg/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Exela Pharma Scs. LLC
  • Approval Date: 16 Apr 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated to meet the nutritional requirements of newborn infants requiring total parenteral nutrition (TPN); and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN. It can also be added to amino acid solutions to provide a more complete profile of amino acids for protein synthesis.
  • Approved Label16 Apr 2019 (PDF)

CORLANOR
  • Active Ingredient(s): Ivabradine
  • Strength: 5 mg/5 mL
  • Dosage Form(s) / Route(s): Solution; oral
  • Company: Amgen Inc.
  • Approval Date: 22 Apr 2019
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicate:
    • To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction
    • For the treatment of stable symptomatic heart failure due to dilated cardiomyopathy in pediatric patients ages 6 months and older. 
  • Approved Label22 Apr 2019 (PDF)
SKYRIZI
  • Active Ingredient(s): Risankizumab-rzaa
  • Strength: 75 mg/0.83 mL
  • Dosage Form(s) / Route(s): Injectable; injective
  • Company: Abbvie Inc.
  • Approval Date: 23 Apr 2019
  • Submission Classification: Not available 
  • Indication(s): Indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
  • Approved Label23 Apr 2019 (PDF)

DUOBRII
  • Active Ingredient(s): Halobetasol propionate; tazarotene
  • Strength: 0.01%; 0.045%
  • Dosage Form(s) / Route(s): Lotion; topical
  • Company: Bausch Health Americas Inc.
  • Approval Date: 25 Apr 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for the topical treatment of plaque psoriasis in adults. 
  • Approved Label25 Apr 2019 (PDF)

ETICOVO
  • Active Ingredient(s): Etanercept-ykro
  • Strength: 25 mg/0.5 mL; 50 mg/1 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Samsung Bioepis Co., Ltd.
  • Approval Date: 25 Apr 2019
  • Submission Classification: Not Available
  • Indication(s): Indicated for the treatment of:
    • Rheumatoid Arthritis (RA)
    • Polyarticular Juvenile Idiopathic Arthritis (JIA) in patients aged 2 years or older
    • Psoriatic Arthritis (PsA)
    • Ankylosing Spondylitis (AS) 
    • Plaque Psoriasis (PsO) in patients 4 years or older
  • Approved Label25 Apr 2019 (PDF)

ZURAGARD  
  • Active Ingredient(s): Isopropyl Alcohol
  • Strength: 70%
  • Dosage Form(s) / Route(s): Solution; topical
  • Company: Zurex Pharma
  • Approval Date: 26 Apr 2019
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated:
    • For preparation of the skin prior to surgery.      
    • To help reduce bacteria that potentially can cause skin infection
  • Approved Label26 Apr 2019 (PDF)

SELENIOUS ACID   
  • Active Ingredient(s): Selenious Acid
  • Strength: 60 mcg/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: American Regent Inc.
  • Approval Date: 30 Apr 2019
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Indicated in adult and pediatric patients as source of selenium for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated.
  • Approved Label30 Apr 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
05 Nov 2019
Low total cholesterol levels appear to carry increased major adverse cardiovascular events (MACE) hazard in older men without ischaemic heart disease (IHD) and not receiving statin therapy but not to those on statins, according to data from the CHAMP (Concord Health and Ageing in Men Project) cohort.
Tristan Manalac, 25 Aug 2017
Using blunt needles to administer local anaesthesia in upper blepharoplasty has a lower risk of haemorrhage and need for interventional pain procedures compared with sharp needles, a new randomized clinical trial has found.
09 Nov 2019
In patients with acute ST-segment elevation myocardial infarction (ASTEMI), the risk of new-onset atrial fibrillation (NOAF) appears to be linked with plasma levels of low-density lipoprotein cholesterol (LDL-C) and total cholesterol (TC), a recent China study has found.
23 Oct 2019
Implementing a high-sensitivity cardiac troponin I assay with sex-specific diagnostic thresholds results in identifying five times more women than men with myocardial injury, reports a study.