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11 May 2020
This second issue revisits the impact EMPA-REG OUTCOME had on clinical practice and helps readers discover how it gives life back to patients through its cardiovascular indication. Learn how it was approved and the possible mechanisms for its cardiovascular benefits.
Stephen Padilla, 22 Jul 2019
Zinc supplementation significantly lowers key glycaemic indicators, particularly fasting glucose (FG) in individuals with diabetes and in those who received an inorganic supplement, results of a systematic review and meta-analysis have shown.
Elaine Soliven, 15 Oct 2020

Higher levels of exercise appear to be associated with a lower risk of all-cause mortality in adults with type 2 diabetes (T2D) compared with no exercise at all, according to a study presented at EASD 2020.

Original New Drug Application Approvals by US FDA (16 - 30 April 2018)

30 Apr 2018

New drug applications approved by US FDA as of 16 - 30 April 2018 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.

TAVALISSE

  • Active Ingredient(s): Fostamatinib
  • Strength: 100MG; 150MG
  • Dosage Form: Tablet
  • Company: Rigel Pharms Inc
  • Approval Date: 17 April 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment
  • Approved Label17/04/2018 (PDF)

CRYSVITA
  • Active Ingredient(s): Burosumab-twza
  • Strength: 10MG/ML
  • Dosage Form: Injectable
  • Company: Ultragenyx Pharm Inc
  • Approval Date: 17 April 2018
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older
  • Approved Label17/04/2018 (PDF)

AKYNZEO
  • Active Ingredient(s): Fosnetupitant; Palonosetron hydrochloride
  • Strength: 235MG; 0.25MG
  • Dosage Form: Injectable
  • Company: Helsinn Healthcare
  • Approval Date: 19 April 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy
  • Approved Label19/04/2018 (PDF)

JYNARQUE
  • Active Ingredient(s): Tolvaptan
  • Strength: 15MG; 30MG; 45MG; 60MG; 90MG
  • Dosage Form: Tablet, chewable tablet, capsule
  • Company: Otsuka Pharm Co Ltd
  • Approval Date: 23 April 2018
  • Submission Classification: Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated
  • Indication(s): Not available
  • Approved Label: Not available

HYDROCODONE BITARTRATE; GUAIFENESIN
  • Active Ingredient(s): Hydrocodone bitartrate; Guaifenesin
  • Strength: 5MG; 400MG
  • Dosage Form: Tablet
  • Company: ECI Pharms LLC
  • Approval Date: 25 April 2018
  • Submission Classification: Type 3 - New Dosage Form and Type 4 - New Combination
  • Indication(s): Indicated for the symptomatic relief of cough and to loosen mucus associated with the common cold in patients 18 years of age and older
  • Approved Label25/04/2018 (PDF)
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Most Read Articles
11 May 2020
This second issue revisits the impact EMPA-REG OUTCOME had on clinical practice and helps readers discover how it gives life back to patients through its cardiovascular indication. Learn how it was approved and the possible mechanisms for its cardiovascular benefits.
Stephen Padilla, 22 Jul 2019
Zinc supplementation significantly lowers key glycaemic indicators, particularly fasting glucose (FG) in individuals with diabetes and in those who received an inorganic supplement, results of a systematic review and meta-analysis have shown.
Elaine Soliven, 15 Oct 2020

Higher levels of exercise appear to be associated with a lower risk of all-cause mortality in adults with type 2 diabetes (T2D) compared with no exercise at all, according to a study presented at EASD 2020.