Most Read Articles
Yesterday
No association exists between physical activity and the risk of urological cancer, according to a population-based prospective study in Japan.
6 days ago
Olanzapine confers a modest therapeutic effect on weight compared with placebo in adult outpatients with anorexia nervosa, a study has shown. However, it does not appear to offer significant benefit for psychological symptoms.
2 days ago
Patients with childhood-onset inflammatory bowel disease are more likely to die than the general population, a study suggests.
2 days ago
Reduced caloric intake results in a significant improvement in glucose metabolism and body-fat composition, including liver-fat content, according to a study. Changes in ferritin levels appear to mediate the striking reduction in liver fat.

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)
Digital Edition
Asia's trusted medical magazine for healthcare professionals. Get your MIMS Doctor - Malaysia digital copy today!
Sign In To Download
Editor's Recommendations
Most Read Articles
Yesterday
No association exists between physical activity and the risk of urological cancer, according to a population-based prospective study in Japan.
6 days ago
Olanzapine confers a modest therapeutic effect on weight compared with placebo in adult outpatients with anorexia nervosa, a study has shown. However, it does not appear to offer significant benefit for psychological symptoms.
2 days ago
Patients with childhood-onset inflammatory bowel disease are more likely to die than the general population, a study suggests.
2 days ago
Reduced caloric intake results in a significant improvement in glucose metabolism and body-fat composition, including liver-fat content, according to a study. Changes in ferritin levels appear to mediate the striking reduction in liver fat.