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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
3 days ago
During the Allergic Rhinitis (AR) Boot Camp held in conjunction with the Bayer Pharmacist Congress 2020, Professor Dr Baharudin Abdullah discussed the management of AR in the primary care setting and the importance of using patient profiles to guide the choice of antihistamines.
Pank Jit Sin, 14 Apr 2020
With the movement control order (MCO) in full gear, most conferences and meetings are being postponed or cancelled. Some have taken to having conferences and meetings in a virtual setting, such as the recently ended American College of Cardiology/World Congress of Cardiology (ACC.20/WCC) conference. MIMS and the Asian Young Pharmacist Group (AYPG) took this opportunity to engage with pharmacists in the form of a Zoom meeting. 
Pearl Toh, 05 Aug 2020
The direct oral anticoagulant apixaban may help prevent deaths when given at prophylactic or therapeutic doses in hospitalized COVID-19 patients with elevated D-dimer levels, according to an analysis presented during the ISTH 2020 Congress.