Most Read Articles
Stephen Padilla, 21 Jul 2017
Adherence to a beneficial lifestyle may significantly reduce the risk of chronic hypertension after hypertensive disorders of pregnancy (HDP) such as gestational hypertension and pre-eclampsia, a recent study suggests. Keeping a healthy weight appears to be critical in women with a history of HDP compared with those without such a history.
Natalia Reoutova, 3 days ago

MitraClip NTR and XTR systems are effective and well tolerated for primary mitral regurgitation (MR), as shown in the prospective, multicentre, single-arm, international, post-marketing, real-world, observational EXPAND study presented at the American College of Cardiology 2020/World Congress of Cardiology (ACC.20/WCC) virtual meeting.

09 Jul 2017
The Dietary Approaches to Stop Hypertension (DASH) diet is effective in reducing uric acid concentrations and risks of gout in males, a new prospective cohort study reveals. In contrast, Western diets up the risk of gout.
Pearl Toh, 4 days ago
Not only is listening to music relaxing for the mind, it may also benefit the heart for patients with early post-infarction angina, suggests a study released during the ACC.20/WCC Virtual Meeting.

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
Stephen Padilla, 21 Jul 2017
Adherence to a beneficial lifestyle may significantly reduce the risk of chronic hypertension after hypertensive disorders of pregnancy (HDP) such as gestational hypertension and pre-eclampsia, a recent study suggests. Keeping a healthy weight appears to be critical in women with a history of HDP compared with those without such a history.
Natalia Reoutova, 3 days ago

MitraClip NTR and XTR systems are effective and well tolerated for primary mitral regurgitation (MR), as shown in the prospective, multicentre, single-arm, international, post-marketing, real-world, observational EXPAND study presented at the American College of Cardiology 2020/World Congress of Cardiology (ACC.20/WCC) virtual meeting.

09 Jul 2017
The Dietary Approaches to Stop Hypertension (DASH) diet is effective in reducing uric acid concentrations and risks of gout in males, a new prospective cohort study reveals. In contrast, Western diets up the risk of gout.
Pearl Toh, 4 days ago
Not only is listening to music relaxing for the mind, it may also benefit the heart for patients with early post-infarction angina, suggests a study released during the ACC.20/WCC Virtual Meeting.