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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
Tristan Manalac, 5 days ago
Left ventricular assist devices (LVADs) can reverse pulmonary hypertension secondary to left heart disease regardless of baseline pulmonary vascular resistance, according to a new study.
15 hours ago
It appears that long-term consumption of fish and omega-3 fatty acid does not influence the risk of incident hypertension in middle-aged and older men, suggests a US study.
11 May 2019
Acute kidney injury (AKI) commonly occurs within a year after cancer diagnosis in paediatric patients and is tied to long-term deteriorations in renal function, a recent study has found.
11 May 2019
Women practicing exclusive breastfeeding for 6 months achieve greater postpartum weight loss compared with those exclusively breastfeeding for a shorter duration, according to data from the MILK* study.