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)
Editor's Recommendations