Most Read Articles
Pearl Toh, 3 days ago
Every-two-month injections of the long-acting cabotegravir + rilpivirine were noninferior to once-monthly injections for virologic suppression at 48 weeks in people living with HIV*, according to the ATLAS-2M** study presented at CROI 2020 — thus providing a potential option with more convenient dosing.
Stephen Padilla, 19 Mar 2020
The assumption that children are less vulnerable to the coronavirus disease 2019 (COVID-19) compared to adults is not quite true and may even be dangerous, suggests a recent study.
22 Mar 2020
Sustained use of lopinavir-combined regimen appears to confer benefits among patients with the novel coronavirus disease (COVID-19), with improvement possibly indicated by increasing eosinophils, suggests a recent study.
6 days ago
COVID-19 is a novel disease, with no existing immunity. The virus can be transmitted from person to person, quickly and exponentially. Here’s what we can do to slow down the spread, if not contain the outbreak.

Original New Drug Application Approvals by US FDA (01 - 15 May 2018)

16 May 2018

New drug applications approved by US FDA as of 01 - 15 May 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.

PLENVU

  • Active Ingredient(s): polyethylene glycol (PEG) 3350; sodium ascorbate; sodium sulfate; ascorbic acid; sodium chloride; potassium chloride
  • Strength: 140G; 48.11G; 9G; 7.54G; 5.2G; 2.2G
  • Dosage Form: Solution
  • Company: Salix Pharms Inc.
  • Approval Date: 04 May 2018
  • Submission Classification: Type 2 - New Active Ingredient
  • Indication(s): Indicated for cleansing of the colon in preparation for colonoscopy in adults
  • Approved Label04/05/2018 (PDF)
LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
  • Active Ingredient(s): Lamivudine; Tenofovir disoproxil fumarate
  • Strength: 300MG; 300MG
  • Dosage Form: Tablet
  • Company: Aurobindo Pharma Ltd.
  • Approval Date: 15 May 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric patients weighing at least 35 kg
  • Approved Label: 15/05/2018 (PDF)
RETACRIT
  • Active Ingredient(s): Epoetin alfa-epbx
  • Strength: 2,000 UNITS/ML;  3,000 UNITS/ML;  4,000 UNITS/ML;  10,000 UNITS/ML;  40,000 UNITS/ML
  • Dosage Form: Injectable
  • Company: Hospira Inc.
  • Approval Date: 15 May 2018
  • Submission Classification: Not available
  • Indication(s): Indicated for:
    • Treatment of anemia due to
      • Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis
      • Zidovudine in patients with HIV-infection
      • The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy
    • Reduction of allogeneic RBC transfusions in patients undergoing elective, noncardiac, nonvascular surgery
  • Approved Label: 15/05/2018 (PDF)
BENDAMUSTINE HYDROCHLORIDE
  • Active Ingredient(s): Bendamustine hydrochloride
  • Strength: 100 MG
  • Dosage Form: Injectable
  • Company: Eagle Pharms
  • Approval Date: 15 May 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer    
  • Indication(s): Indicated for treatment of patients with:
    • Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established
    • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen
  • Approved Label28/05/2018 (PDF)
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Most Read Articles
Pearl Toh, 3 days ago
Every-two-month injections of the long-acting cabotegravir + rilpivirine were noninferior to once-monthly injections for virologic suppression at 48 weeks in people living with HIV*, according to the ATLAS-2M** study presented at CROI 2020 — thus providing a potential option with more convenient dosing.
Stephen Padilla, 19 Mar 2020
The assumption that children are less vulnerable to the coronavirus disease 2019 (COVID-19) compared to adults is not quite true and may even be dangerous, suggests a recent study.
22 Mar 2020
Sustained use of lopinavir-combined regimen appears to confer benefits among patients with the novel coronavirus disease (COVID-19), with improvement possibly indicated by increasing eosinophils, suggests a recent study.
6 days ago
COVID-19 is a novel disease, with no existing immunity. The virus can be transmitted from person to person, quickly and exponentially. Here’s what we can do to slow down the spread, if not contain the outbreak.