Original New Drug Application Approvals by US FDA (01 - 15 November 2020)

18 Nov 2020
New drug applications approved by US FDA as of 01 - 15 November 2020 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.

SESQUIENT
  • Active Ingredient(s): Fosphenytoin sodium
  • Strength: 500 mg/10 mL (50 mg PE/mL); 100 mg/2 mL (50 mg PE/mL)
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Sedor Pharmaceuticals LLC
  • Approval Date: 05 November 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated:
    • for the treatment of generalized tonic-clonic status epilepticus in adult patients
    • prevention and treatment of seizures occurring during neurosurgery in adult patients
    • for short-term substitution for oral phenytoin in patients 2 years of age and older. 
  • Approved Label05 November 2020 (PDF)

LABETALOL HYDROCHLORIDE IN DEXTROSE
  • Active Ingredient(s): Labetalol hydrochloride
  • Strength: 100 mg/100 mL; 200 mg/200 mL; 300 mg/300 mL
  • Dosage Form(s) / Route(s): Injectable; injection
  • Company: Hikma Pharmaceuticals International Limited
  • Approval Date: 09 November 2020
  • Submission Classification: Type 5 - New Formulation or New Manufacturer
  • Indication(s): Indicated in severe hypertension, to lower blood pressure. 
  • Approved Label09 November 2020 (PDF)

SUTAB
  • Active Ingredient(s): Sodium sulfate; magnesium sulfate; potassium
  • Strength: 1.479 g; 0.225 g; 0.188 g
  • Dosage Form(s) / Route(s):Tablet; oral
  • Company: Braintree Labs
  • Approval Date: 10 November 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for cleansing of the colon in preparation for colonoscopy in adults.
  • Approved Label10 November 2020 (PDF)
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