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