Most Read Articles
Joyce Lam Ching Mei, 28 Mar 2019
April 17 marks World Haemophilia Day, and this year’s theme is  “Reaching Out – The First Step to Care”. Adjunct Assoc Prof Joyce Lam Ching Mei, head of the Haematology Laboratory and Blood Bank and senior consultant from the Paediatric Haematology/Oncology Service at KK Women’s and Children’s Hospital, Singapore, speaks to Elaine Soliven on the importance of recognizing and managing bleeding disorders in primary care.
Tristan Manalac, 05 Nov 2019
Vaping nontraditional e-cigarette flavours, such as fruit and candy, supports the habit and may promote more frequent use, according to a new study.
Stephen Padilla, 31 Oct 2019
Intraoperative epidural analgesia, perioperative opioid and total dose of volatile agent appear to show some “clinically meaningful associations” with relapse-free survival (RFS) in children with solid organ tumour, particularly in paediatric sarcoma patients, according to a Singapore study. However, no statistically significant association exists between epidural use and an improved RFS.

Original New Drug Application Approvals by US FDA (16 - 30 November 2017)

30 Nov 2017

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

HEMLIBRA

  • Active Ingredient(s): Emicizumab
  • Strength: 30mg/ml; 60mg/0.4ml; 105mg/0.7ml; 150mg
  • Dosage Form: Injectable;injection
  • Company: Genentech Inc
  • Approval Date: November 16, 2017
  • Submission Classification: Not available
  • Indication(s): Indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.
  • Approved Label: 11/16/2017(PDF)

PALONOSETRON
  • Active Ingredient(s): Palonosetron Hydrochloride
  • Strength: 0.25mg/ml
  • Dosage Form: Injectable;injection
  • Company: Fresenius Kabi USA
  • Approval Date: November 21, 2017
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in adults for:
    • Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses. 
    • Highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses.
    • Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery. Efficacy beyond 24 hours has not been demonstrated.
  • Approved Label: 11/21/2017(PDF)
JULUCA
  • Active Ingredient(s): Dolutegravir;Rilpivirine
  • Strength: 50mg;25mg
  • Dosage Form: Tablet;oral
  • Company: VIIV Hlthcare
  • Approval Date:  November 21, 2017
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of JULUCA.
  • Approved Label: 11/21/2017(PDF)
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Most Read Articles
Joyce Lam Ching Mei, 28 Mar 2019
April 17 marks World Haemophilia Day, and this year’s theme is  “Reaching Out – The First Step to Care”. Adjunct Assoc Prof Joyce Lam Ching Mei, head of the Haematology Laboratory and Blood Bank and senior consultant from the Paediatric Haematology/Oncology Service at KK Women’s and Children’s Hospital, Singapore, speaks to Elaine Soliven on the importance of recognizing and managing bleeding disorders in primary care.
Tristan Manalac, 05 Nov 2019
Vaping nontraditional e-cigarette flavours, such as fruit and candy, supports the habit and may promote more frequent use, according to a new study.
Stephen Padilla, 31 Oct 2019
Intraoperative epidural analgesia, perioperative opioid and total dose of volatile agent appear to show some “clinically meaningful associations” with relapse-free survival (RFS) in children with solid organ tumour, particularly in paediatric sarcoma patients, according to a Singapore study. However, no statistically significant association exists between epidural use and an improved RFS.