Most Read Articles
29 Jul 2020
Adjunctive perampanel appears to be safe and effective for long-term treatment of patients with tonic‐clonic seizures, according to a posthoc analysis.
27 Apr 2020
Long-term use of brivaracetam as an adjunctive treatment is well tolerated and effective in patients with focal seizures or primary generalized seizures, as shown in a study.
01 Apr 2019
Perampanel is safe and effective for treating refractory focal seizures in both Asian and non‐Asian populations, a study has found.
Rachel Soon, 24 Apr 2018

MIMS Pharmacist presents an overview of CoQ10's physiological role, as well as contemporary research on its pharmacology and effects.

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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Editor's Recommendations
Most Read Articles
29 Jul 2020
Adjunctive perampanel appears to be safe and effective for long-term treatment of patients with tonic‐clonic seizures, according to a posthoc analysis.
27 Apr 2020
Long-term use of brivaracetam as an adjunctive treatment is well tolerated and effective in patients with focal seizures or primary generalized seizures, as shown in a study.
01 Apr 2019
Perampanel is safe and effective for treating refractory focal seizures in both Asian and non‐Asian populations, a study has found.
Rachel Soon, 24 Apr 2018

MIMS Pharmacist presents an overview of CoQ10's physiological role, as well as contemporary research on its pharmacology and effects.