Original New Drug Application Approvals by US FDA (01 - 15 November 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 Label: 05 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 Label: 09 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 Label: 10 November 2020 (PDF)