Most Read Articles
01 Nov 2019
Women with hypertensive disorders of pregnancy, especially pre-eclampsia, are at heightened risk of developing cardiovascular disorder and chronic hypertension, with the risk becoming apparent soon after pregnancy, a study has found.
Roshini Claire Anthony, 29 May 2019

Gestational diabetes and abnormal glucose levels in pregnancy, as determined with an oral glucose challenge test (OGCT) at 24–28 weeks gestation, could signal a future risk of cardiovascular disease (CVD)*, according to a recent study.

07 Jul 2019
Plasma creatinine kinase activity, measure during early pregnancy, influences blood pressure during pregnancy and contributes to severe gestational hypertension diagnosed before 34 weeks of gestation, according to a recent study. There is no association between creatinine kinase and other hypertensive disorders during pregnancy.
Pank Jit Sin, 16 Oct 2019
While a diagnosis of cancer is often met with concern and devastation, the same is barely true for heart failure. However, the mortality rate for those suffering from heart failure is worse than some common cancers, such as prostate and breast cancers. 

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
01 Nov 2019
Women with hypertensive disorders of pregnancy, especially pre-eclampsia, are at heightened risk of developing cardiovascular disorder and chronic hypertension, with the risk becoming apparent soon after pregnancy, a study has found.
Roshini Claire Anthony, 29 May 2019

Gestational diabetes and abnormal glucose levels in pregnancy, as determined with an oral glucose challenge test (OGCT) at 24–28 weeks gestation, could signal a future risk of cardiovascular disease (CVD)*, according to a recent study.

07 Jul 2019
Plasma creatinine kinase activity, measure during early pregnancy, influences blood pressure during pregnancy and contributes to severe gestational hypertension diagnosed before 34 weeks of gestation, according to a recent study. There is no association between creatinine kinase and other hypertensive disorders during pregnancy.
Pank Jit Sin, 16 Oct 2019
While a diagnosis of cancer is often met with concern and devastation, the same is barely true for heart failure. However, the mortality rate for those suffering from heart failure is worse than some common cancers, such as prostate and breast cancers.