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Original New Drug Application Approvals by US FDA (15 - 31 December 2018)

31 Dec 2018
New drug applications approved by US FDA as of 15 - 31 December 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.

EZALLORT
  • Active Ingredient(s): Rosuvastatin
  • Strength: 5 MG; 10 MG; 20 MG; 40 MG
  • Dosage Form(s) / Route(s): Capsul; Oral
  • Company: Sun Pharma Global
  • Approval Date: 18 Dec 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for:
    • adult patients with hypertriglyceridemia as an adjunct to diet; 
    • adult patients with primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet;
    • adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total-C, and ApoB.
  • Approved Label: 18 Dec 2018 (PDF)
LICART
  • Active Ingredient(s): Diclofenac epolamine
  • Strength: 1.3%
  • Dosage Form(s) / Route(s): Shampoo; Topical
  • Company: Institut Biochemique
  • Approval Date: 19 Dec 2018
  • Submission Classification: Type 3 - New Dosage Form and Type 4 - New Combination
  • Indication(s): Indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions
  • Approved Label: 19 Dec 2018 (PDF)
ELEPSIA XR
  • Active Ingredient(s): Levetiracetam
  • Strength: 1000MG; 1500MG
  • Dosage Form(s) / Route(s): Tablet, extended release; Oral
  • Company: Sun Pharma Global
  • Approval Date: 20 Dec 2018
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older
  • Approved Label: 20 Dec 2018 (PDF)
ASPARLAS
  • Active Ingredient(s): Calaspargase pegol - mknl
  • Strength: 3750UNITS/5ML
  • Dosage Form(s) / Route(s): Injectable; Intravenous
  • Company: Servier Pharma LLC
  • Approval Date: 20 Dec 2018
  • Submission Classification: Not available
  • Indication(s): Indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia in pediatric and young adult patients age 1 month to 21 year
  • Approved Label: 20 Dec 2018 (PDF)
INBRIJA
  • Active Ingredient(s): Levodopa
  • Strength: 42MG
  • Dosage Form(s) / Route(s): Powder; Inhalation
  • Company: Acorda
  • Approval Date: 21 Dec 2018
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the intermittent treatment of OFF episodes in patients with Parkinson’s disease treated with carbidopa/levodopa
  • Approved Label: 21 Dec 2018 (PDF)
ULTOMIRIS
  • Active Ingredient(s): Ravulizumab-cwv
  • Strength: 300MG/30ML (10MG/ML) 
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Alexion Pharm
  • Approval Date: 21 Dec 2018
  • Submission Classification: Not Available
  • Indication(s): Indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH)
  • Approved Label: 21 Dec 2018 (PDF)
ELZONRIS
  • Active Ingredient(s): Tagraxofusp-erzs
  • Strength: 1000MCG
  • Dosage Form(s) / Route(s): Solution; Injection
  • Company: Stemline Therapeutics Inc
  • Approval Date: 21 Dec 2018
  • Submission Classification: Not Available
  • Indication(s): Indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older
  • Approved Label: 21 Dec 2018 (PDF)
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Most Read Articles
4 days ago
Cardiac biomarkers are useful for identifying community-acquired pneumonia (CAP) patients with an elevated risk of early and long-term cardiovascular (CV) events, according to a study.
2 days ago
Tofogliflozin is safe and effective for elderly patients with type 2 diabetes mellitus (T2DM), regardless of insulin and oral antidiabetic drugs, reports a new Japan study.
17 Aug 2019
Pulmonary function has potential predictive value for future increases in arterial stiffness and its progression, as reported in a recent study.
6 days ago
Systolic blood pressure appears to have a strong association with aneurysmal subarachnoid haemorrhage (aSAH) but not with unruptured intracranial aneurysm (UIA), whereas current smoking and female sex are risk factors for both conditions, a study has found.