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Pearl Toh, 4 days ago
Not only does the CGRP* inhibitor galcanezumab show sustained efficacy in migraine patients, long-term treatment does not come with excess cardiovascular (CV) risk, according to studies presented at the AAN 2021 Annual Meeting.
01 Apr 2021
Migraine and headache are common ailments of people living in the modern era. Dr Jon Marshall of The Singapore Headache and Migraine Clinic shares his insights with Pearl Toh on how to manage migraine and headache using non-pharmaceutical strategies, with a focus on the manual medicine approach.
Elvira Manzano, 3 days ago
An investigational transdermal amphetamine patch worn for 9 hours on the hip appeared effective in paediatric patients with attention deficit-hyperactivity disorder (ADHD) in a phase II, two-part trial.
Tristan Manalac, 5 days ago
Visceral fat area is the strongest indicator of mobility disability among obese, community-dwelling, older adults, according to a recent Singapore study.

Original New Drug Application Approvals by US FDA (16 - 31 March 2021)

01 Apr 2021
New drug applications approved by US FDA as of 16-31 March 2021 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.

DOLUTEGRAVIR SODIUM
  • Active Ingredient(s): Dolutegravir Sodium
  • Strength: 10MG
  • Dosage Form(s) / Route(s): Tablet; Oral Suspension
  • Company: AB Pharmaceuticals, LLC
  • Approval Date: 16 Mar 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Not available
  • Approved Label: Not available
PONVORY
  • Active Ingredient(s): Ponesimod
  • Strength: 2MG; 3MG; 4MG; 5MG; 6MG; 7MG; 8MG; 9MG; 10MG; 20MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Janssen Pharms
  • Approval Date: 18 Mar 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
  • Approved Label: 18 Mar 2021 (PDF)
MIDAZOLAM IN SODIUM CHLORIDE
  • Active Ingredient(s): Midazolam
  • Strength: 1MG/ML
  • Dosage Form(s) / Route(s): Solution; Intravenous
  • Company: Inforlife
  • Approval Date: 22 Mar 2021
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated for continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting.
  • Approved Label: 22 Mar 2021 (PDF)
ZEGALOGUE
  • Active Ingredient(s): Dasiglucagon Hydrochloride
  • Strength: 0.6MG/0.6ML
  • Dosage Form(s) / Route(s): Injectable; Injection
  • Company: Zealand Pharma AS
  • Approval Date: 22 Mar 2021
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.
  • Approved Label: 22 Mar 2021 (PDF)
ROSZET
  • Active Ingredient(s): Rosuvastatin Calcium; Ezetimibe
  • Strength: 5MG/10MG; 10MG/10MG; 20MG/10MG; 40MG/10MG
  • Dosage Form(s) / Route(s): Tablet; Oral
  • Company: Althera Life Sciences, LLC.
  • Approval Date: 23 Mar 2021
  • Submission Classification: Type 4 - New Combination
  • Indication(s): Indicated in adults:
    • As an adjunct to diet in patients with primary non-familial hyperlipidemia to reduce low-density lipoprotein cholesterol (LDLC). 
    • Alone or as an adjuct to other LDL-C lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C
  • Approved Label: 23 Mar 2021 (PDF)
MYRBETRIQ
  • Active Ingredient(s): Mirabegron
  • Strength: 8MG/ML
  • Dosage Form(s) / Route(s): Suspension; Oral
  • Company: Astellas Pharma Global Dev Inc
  • Approval Date: 25 Mar 2021
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the treatment of:
    • Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency, either alone or in combination with the muscarinic antagonist solifenacin succinate.
    • Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more.
    • NDO in pediatric patients aged 3 years and older. 
  • Approved Label: 25 Mar 2021 (PDF)
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Most Read Articles
Pearl Toh, 4 days ago
Not only does the CGRP* inhibitor galcanezumab show sustained efficacy in migraine patients, long-term treatment does not come with excess cardiovascular (CV) risk, according to studies presented at the AAN 2021 Annual Meeting.
01 Apr 2021
Migraine and headache are common ailments of people living in the modern era. Dr Jon Marshall of The Singapore Headache and Migraine Clinic shares his insights with Pearl Toh on how to manage migraine and headache using non-pharmaceutical strategies, with a focus on the manual medicine approach.
Elvira Manzano, 3 days ago
An investigational transdermal amphetamine patch worn for 9 hours on the hip appeared effective in paediatric patients with attention deficit-hyperactivity disorder (ADHD) in a phase II, two-part trial.
Tristan Manalac, 5 days ago
Visceral fat area is the strongest indicator of mobility disability among obese, community-dwelling, older adults, according to a recent Singapore study.