Most Read Articles
07 Sep 2019
Eating mushrooms has no correlation with biomarkers and risks of cardiovascular disease (CVD) and type 2 diabetes (T2D) in adults, a US study has shown.
03 Sep 2019
Sleep apnoea is highly prevalent but largely undetected in the general population of middle-aged adults, with a symptom-based strategy proving to be useless for specific diagnosis, according to a recent study. Moreover, mild sleep apnoea represents a higher-risk phenotype with manifestly increased metabolic, inflammatory and cardiovascular risk factor burden, with potential public health implications.
Rachel Soon, 2 days ago

Adding simvastatin as an adjuvant to standard triple therapy in Helicobacter pylori treatment may help compensate for increasing antimicrobial resistance, according to a new study.

Christina Lau, 03 Sep 2019
The sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin significantly reduces the risk of death and hospitalization in patients with heart failure (HF) with reduced ejection fraction (rEF) regardless of whether they have type 2 diabetes mellitus (T2DM), the DAPA-HF trial has shown.

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)
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Most Read Articles
07 Sep 2019
Eating mushrooms has no correlation with biomarkers and risks of cardiovascular disease (CVD) and type 2 diabetes (T2D) in adults, a US study has shown.
03 Sep 2019
Sleep apnoea is highly prevalent but largely undetected in the general population of middle-aged adults, with a symptom-based strategy proving to be useless for specific diagnosis, according to a recent study. Moreover, mild sleep apnoea represents a higher-risk phenotype with manifestly increased metabolic, inflammatory and cardiovascular risk factor burden, with potential public health implications.
Rachel Soon, 2 days ago

Adding simvastatin as an adjuvant to standard triple therapy in Helicobacter pylori treatment may help compensate for increasing antimicrobial resistance, according to a new study.

Christina Lau, 03 Sep 2019
The sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin significantly reduces the risk of death and hospitalization in patients with heart failure (HF) with reduced ejection fraction (rEF) regardless of whether they have type 2 diabetes mellitus (T2DM), the DAPA-HF trial has shown.