Most Read Articles
Pearl Toh, 3 days ago
Antiviral treatment with tenofovir alafenamide fumarate (TAF) during pregnancy in highly viraemic mothers effectively prevents mother-to-child transmission (MTCT) of hepatitis B virus (HBV) with no safety concerns, according to two studies presented during the AASLD 2020 Liver Meeting.

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
Pearl Toh, 3 days ago
Antiviral treatment with tenofovir alafenamide fumarate (TAF) during pregnancy in highly viraemic mothers effectively prevents mother-to-child transmission (MTCT) of hepatitis B virus (HBV) with no safety concerns, according to two studies presented during the AASLD 2020 Liver Meeting.