Most Read Articles
2 days ago
Age and sex do not appear to influence outcomes after percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) for left main coronary artery disease, reports a recent study.
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.
23 Jun 2019
Implementing the 2017 American College of Cardiology/American Heart Association (ACC/AHA) guideline over that of the 2018 European Society of Cardiology/European Society of Hypertension (ESC/ESH) will give rise to a substantial increase in the prevalence of hypertension, as well as the number of adults who should receive medication, according to 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)
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Most Read Articles
2 days ago
Age and sex do not appear to influence outcomes after percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) for left main coronary artery disease, reports a recent study.
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.
23 Jun 2019
Implementing the 2017 American College of Cardiology/American Heart Association (ACC/AHA) guideline over that of the 2018 European Society of Cardiology/European Society of Hypertension (ESC/ESH) will give rise to a substantial increase in the prevalence of hypertension, as well as the number of adults who should receive medication, according to a study.