Most Read Articles
Roshini Claire Anthony, 28 Jan 2020

Individuals with type 2 diabetes (T2D) who are prescribed an SGLT2* inhibitor may have a reduced risk for developing gout compared with those who are prescribed a GLP-1** receptor agonist, according to a study from the US.

Jairia Dela Cruz, 27 Jan 2020
Bariatric surgery is beneficial to nondiabetic Asian patients with obesity, delivering sustained weight loss in addition to normalizing sugar levels and insulin resistance within 1–3 years of the procedure, as reported in a Singapore study.
3 days ago
Sleep disorder in nonstandard shift workers appears to contribute to more severe hypogonadal symptoms and lower testosterone levels when compared with daytime workers and nonstandard shift workers without sleep disorder, according to a study.
12 Nov 2019
Markedly different blood glucose responses and postexercise profiles are associated with fasting morning resistance exercise (RE) compared with afternoon RE in individuals with type 1 diabetes (T1D), a recent study has shown.

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
Roshini Claire Anthony, 28 Jan 2020

Individuals with type 2 diabetes (T2D) who are prescribed an SGLT2* inhibitor may have a reduced risk for developing gout compared with those who are prescribed a GLP-1** receptor agonist, according to a study from the US.

Jairia Dela Cruz, 27 Jan 2020
Bariatric surgery is beneficial to nondiabetic Asian patients with obesity, delivering sustained weight loss in addition to normalizing sugar levels and insulin resistance within 1–3 years of the procedure, as reported in a Singapore study.
3 days ago
Sleep disorder in nonstandard shift workers appears to contribute to more severe hypogonadal symptoms and lower testosterone levels when compared with daytime workers and nonstandard shift workers without sleep disorder, according to a study.
12 Nov 2019
Markedly different blood glucose responses and postexercise profiles are associated with fasting morning resistance exercise (RE) compared with afternoon RE in individuals with type 1 diabetes (T1D), a recent study has shown.