Most Read Articles
Stephen Padilla, 03 Aug 2018
It appears that the two-dose AS04-adjuvanted HPV-16/18 vaccine (AS04-HPV-16/18v) is the most cost-effective choice for lowering the burden of cervical cancer through universal mass vaccination for 12-year-old girls in Singapore from the perspective of the healthcare payer (MOH Singapore), according to a recent study.
25 Apr 2020
The human papillomavirus (HPV) DNA vaccine (GX-188E) is effective against HPV type 16/18–associated cervical intraepithelial neoplasia (CIN) 3, according to the results of a phase II trial.
Audrey Abella, 02 Jul 2020
The highly selective SGLT2 inhibitor bexagliflozin demonstrated significant efficacy and safety in controlling hyperglycaemia, weight, and blood pressure (BP) in patients with type 2 diabetes (T2D) who were at high risk of cardiovascular (CV) events, results of the BEST** trial have shown.
18 Jul 2019
In the treatment of patients with human papillomavirus-positive oropharyngeal squamous cell carcinoma (HPV+ OPSCC), de-escalating dose and volume of radiotherapy (RT) or chemoradiotherapy (CRT) based on response to induction chemotherapy appears to positively affect oncologic outcomes and reduce toxicity, according to data from the phase II OPTIMA trial.

Original New Drug Application Approvals by US FDA (01 - 15 June 2020)

16 Jun 2020
New drug applications approved by US FDA as of 01 - 15 June 2020 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.

NYVEPRIA
  • Active Ingredient(s): Pegfilgrastim-apgf
  • Strength: 6 mg/0.6 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Hospira, Inc.
  • Approval Date: 10 June 2020
  • Submission Classification: Not available
  • Indication(s): Indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
  • Approved Label10 June 2020 (PDF)

SEMGLEE
  • Active Ingredient(s): Insulin glargine
  • Strength: 100 units/mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Mylan Pharms, Inc.
  • Approval Date: 11 June 2020
  • Submission Classification: Not available
  • Indication(s): Indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
  • Approved Label11 June 2020 (PDF)

UPLIZNA 
  • Active Ingredient(s): Inebilizumab
  • Strength: 100 mg/10 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Viela Bio
  • Approval Date: 11 June 2020
  • Submission Classification: Not available
  • Indication(s): Indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
  • Approved Label11 June 2020 (PDF)

TIVICAY PD
  • Active Ingredient(s): Dolutegravir
  • Strength: 5 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Viiv Healthcare
  • Approval Date: 12 June 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s)
    • Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but INSTI-naïve) aged at least 4 weeks and weighing at least 3 kg.
    • Indicated in combination with rilpivirine 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 or known substitutions associated with resistance to either antiretroviral agent.
  • Approved Label12 June 2020 (PDF)

ZEPZELCA
  • Active Ingredient(s): Lurbinectedin
  • Strength: 4 mg
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Pharma Mar USA, Inc.
  • Approval Date: 15 June 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
  • Approved Label15 June 2020 (PDF)

LYUMJEV
  • Active Ingredient(s): Insulin lispro-aabc
  • Strength: 100 units/mL (U-100); 200 units/mL (U-200)
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Eli Lilly and Co.
  • Approval Date: 15 June 2020
  • Submission Classification: Not available
  • Indication(s): Indicated to improve glycemic control in adults with diabetes mellitus.
  • Approved Label15 June 2020 (PDF)
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Most Read Articles
Stephen Padilla, 03 Aug 2018
It appears that the two-dose AS04-adjuvanted HPV-16/18 vaccine (AS04-HPV-16/18v) is the most cost-effective choice for lowering the burden of cervical cancer through universal mass vaccination for 12-year-old girls in Singapore from the perspective of the healthcare payer (MOH Singapore), according to a recent study.
25 Apr 2020
The human papillomavirus (HPV) DNA vaccine (GX-188E) is effective against HPV type 16/18–associated cervical intraepithelial neoplasia (CIN) 3, according to the results of a phase II trial.
Audrey Abella, 02 Jul 2020
The highly selective SGLT2 inhibitor bexagliflozin demonstrated significant efficacy and safety in controlling hyperglycaemia, weight, and blood pressure (BP) in patients with type 2 diabetes (T2D) who were at high risk of cardiovascular (CV) events, results of the BEST** trial have shown.
18 Jul 2019
In the treatment of patients with human papillomavirus-positive oropharyngeal squamous cell carcinoma (HPV+ OPSCC), de-escalating dose and volume of radiotherapy (RT) or chemoradiotherapy (CRT) based on response to induction chemotherapy appears to positively affect oncologic outcomes and reduce toxicity, according to data from the phase II OPTIMA trial.