Most Read Articles
Roshini Claire Anthony, 04 Apr 2019

In addition to an intensive weight loss programme, the use of continuous positive airway pressure (CPAP) could improve absolute weight loss in individuals with obesity and obstructive sleep apnoea (OSA), according to a study presented at ENDO 2019.

4 days ago
The ketogenic and Modified Atkin’s diets are effective treatments for children with refractory epilepsy of genetic aetiology, a new study suggests.
5 days ago
Extremely premature neonates who have been exposed to pre-eclampsia in utero are at high risk of developing severe respiratory distress syndrome and severe bronchopulmonary dysplasia, according to a study.
Pearl Toh, 4 days ago
A contraceptive vaginal system (Annovera) releasing a combination of segesterone acetate and ethinyl estradiol (SA/EE) effectively inhibits ovulation up to a year even at low systemic levels of SA, reports a review study presented at ENDO 2019.

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
Roshini Claire Anthony, 04 Apr 2019

In addition to an intensive weight loss programme, the use of continuous positive airway pressure (CPAP) could improve absolute weight loss in individuals with obesity and obstructive sleep apnoea (OSA), according to a study presented at ENDO 2019.

4 days ago
The ketogenic and Modified Atkin’s diets are effective treatments for children with refractory epilepsy of genetic aetiology, a new study suggests.
5 days ago
Extremely premature neonates who have been exposed to pre-eclampsia in utero are at high risk of developing severe respiratory distress syndrome and severe bronchopulmonary dysplasia, according to a study.
Pearl Toh, 4 days ago
A contraceptive vaginal system (Annovera) releasing a combination of segesterone acetate and ethinyl estradiol (SA/EE) effectively inhibits ovulation up to a year even at low systemic levels of SA, reports a review study presented at ENDO 2019.