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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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Most Read Articles
4 days ago
Ivermectin confers benefits in the treatment of COVID-19, with a recent study showing that its use helps reduce the risk of death especially in patients with severe pulmonary involvement.
3 days ago
Mental health comorbidities are common among patients with type 2 diabetes mellitus and may lead to worse outcomes, a recent study has found.
Roshini Claire Anthony, 13 Nov 2020

Diabetes is a key risk factor for heart failure (HF), which is the leading cause of hospitalization in patients with or without diabetes. SGLT-2* inhibitors (SGLT-2is) have been shown to reduce the risk of hospitalization for HF (HHF) regardless of the presence or absence of diabetes.

Tristan Manalac, 18 Nov 2020
The substitution of isoleucine to leucine at amino acid 97 (I97L) in the core region of the hepatitis B virus (HBV) seems to reduce its potency, decreasing the efficiency of both infection and the synthesis of the virus’ covalently closed circular (ccc) DNA, reports a new study presented at The Liver Meeting Digital Experience by the American Association for the Study of Liver Diseases (AASLD 2020).