Most Read Articles
6 days ago
Older women with longer endogenous oestrogen exposure and hormone therapy use are at much higher odds of having favourable cognitive status in late life, a recent study suggests.
4 days ago
In patients with atrial fibrillation (AF) and stable coronary artery disease (CAD), rivaroxaban monotherapy is noninferior to combination treatment with an antiplatelet therapy in terms of cutting the risk of cardiovascular events and mortality, according to data from the AFIRE trial.
Elvira Manzano, 5 days ago
Supplementation with omega-3 fatty acids or vitamin D3 for up to 5 years has no effect on kidney function in adults with type 2 diabetes (T2D), the VITAL-DKD* ancillary study has shown.
Jairia Dela Cruz, 2 days ago
Many patients with nonvalvular atrial fibrillation (NVAF) in Thailand use anticoagulants, but the uptake of nonvitamin-K oral anticoagulants remains suboptimal despite showing an upward trend, according to data from the COOL-AF registry presented at the European Society of Cardioloy (ESC) Asia Congress 2019 with APSC and AFC.

Original New Drug Application Approvals by US FDA (16 - 30 November 2018)

30 Nov 2018
New drug applications approved by US FDA as of 16 - 30 November 2018 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.

AEMCOLO
  • Active Ingredient(s): Rifamycin
  • Strength: 192 MG
  • Dosage Form(s) / Route(s): Tablet, Delayed Release; Oral
  • Company: Cosmo Technologies LTD
  • Approval Date: 16 Nov 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in adults
  • Approved Label16 Nov 2018 (PDF)
TEMIXYS
  • Active Ingredient(s): Lamivudine; Tenofovir Disoproxil Fumarate
  • Strength: 300 MG; 300 MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Medline Industries Inc
  • Approval Date: 16 Nov 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg
  • Approved Label: 16 Nov 2018 (PDF)
READYPREP CHG
  • Active Ingredient(s): Chlorhexidine Gluconate
  • Strength: 2%
  • Dosage Form(s) / Route(s): Cloth; Topical
  • Company: Medline Industries Inc
  • Approval Date: 20 Nov 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not Available
  • Approved Label: Not Available
GAMIFANT
  • Active Ingredient(s): Emapalumab-LZSG
  • Strength: 10MG/2ML; 50ML/10ML
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Novimmune S.A.
  • Approval Date: 20 Nov 2018
  • Submission Classification: Not Available
  • Indication(s): Indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy
  • Approved Label20 Nov 2018 (PDF)
DAURISMO
  • Active Ingredient(s): Glasdegib
  • Strength: 25MG; 100MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Pfizer Inc
  • Approval Date: 21 Nov 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy
  • Approved Label21 Nov 2018 (PDF)
SPY AGENT GREEN
  • Active Ingredient(s): Indocyanine Green
  • Strength: 25MG
  • Dosage Form(s) / Route(s): Power; Intravenous
  • Company: Novadaq Technologies ULC
  • Approval Date: 21 Nov 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for use with a fluorescence imaging device for: 
  • Approved Label21 Nov 2018 (PDF)
VITRAKVI
  • Active Ingredient(s): Larotrectinib
  • Strength: 25MG; 100MG
  • Dosage Form(s) / Route(s): Capsule; Oral
  • Company: Loxo Oncology Inc
  • Approval Date: 26 Nov 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adult and pediatric patients with solid tumors that: 
    • have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,  
    • are metastatic or where surgical resection is likely to result in severe morbidity, and 
    • have no satisfactory alternative treatments or that have progressed following treatment. 
  • Approved Label26 Nov 2018 (PDF)
FIRDAPSE
  • Active Ingredient(s): Amifampridine
  • Strength: 10MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Catalyst Pharma Inc
  • Approval Date: 28 Nov 2018
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults .
  • Approved Label28 Nov 2018
XOSPATA
  • Active Ingredient(s): Gilteritinib
  • Strength: 40MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Astellas
  • Approval Date: 28 Nov 2018
  • Submission Classification: Type 1 - New Molecular Entity    
  • Indication(s): Indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.
  • Approved Label28 Nov 2018
TRUXIMA
  • Active Ingredient(s): Rituximab-abbs
  • Strength: 100MG/10ML (10 MG/ML); 500MG/50ML (10 MG/ML)
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Celltrion Inc
  • Approval Date: 28 Nov 2018 
  • Submission Classification: Not Available
  • Indication(s): Indicated for the treatment of adult patients with Non-Hodgkin’s Lymphoma (NHL) 
  • Approved Label: 28 Nov 2018 (PDF)
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Most Read Articles
6 days ago
Older women with longer endogenous oestrogen exposure and hormone therapy use are at much higher odds of having favourable cognitive status in late life, a recent study suggests.
4 days ago
In patients with atrial fibrillation (AF) and stable coronary artery disease (CAD), rivaroxaban monotherapy is noninferior to combination treatment with an antiplatelet therapy in terms of cutting the risk of cardiovascular events and mortality, according to data from the AFIRE trial.
Elvira Manzano, 5 days ago
Supplementation with omega-3 fatty acids or vitamin D3 for up to 5 years has no effect on kidney function in adults with type 2 diabetes (T2D), the VITAL-DKD* ancillary study has shown.
Jairia Dela Cruz, 2 days ago
Many patients with nonvalvular atrial fibrillation (NVAF) in Thailand use anticoagulants, but the uptake of nonvitamin-K oral anticoagulants remains suboptimal despite showing an upward trend, according to data from the COOL-AF registry presented at the European Society of Cardioloy (ESC) Asia Congress 2019 with APSC and AFC.