Original New Drug Application Approvals by US FDA (16 - 30 September 2019)

New drug applications approved by US FDA as of 16 - 30 September 2019 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.




OZOBAX

• Active Ingredient(s): Baclofen
• Strength: 5mg/mL
• Dosage Form(s) / Route(s): Solution; oral
• Company: Metacal Pharma, LLC
• Approval Date: 18 September 2019
• Submission Classification: Type 3 - New Dosage Form
• Indication(s):
  • Indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
  • May also be of some value in patients with spinal cord injuries and other spinal cord diseases.
• Approved Label: 18 September 2019 (PDF)

POTASSIUM PHOSPHATES

• Active Ingredient(s): Potassium phosphates
• Strength: 3 mmol/mL; 4.7 mEq/mL
• Dosage Form(s) / Route(s): Injectable; injection
• Company: CMP Development, LLC
• Approval Date: 19 September 2019
• Submission Classification: Type 5 - New Formulation or New Manufacturer
• Indication(s): Indicated as a source of phosphorus:
  • in intravenous fluids to correct hypophosphatemia in adults and pediatric patients 12 years of age and older when oral or enteral replacement is not possible, insufficient or contraindicated.
  • for parenteral nutrition in adults weighing at least 45 kg and pediatric patients 12 years of age and older weighing at least 40 kg when oral or enteral nutrition is not possible, insufficient or contraindicated.
• Approved Label: 19 September 2019 (PDF)

RYBELSUS

• Active Ingredient(s): Semaglutide
• Strength: 3 mg; 7 mg; 14 mg
• Dosage Form(s) / Route(s): Tablet; oral
• Company: Novo Nordisk, Inc.
• Approval Date: 20 September 2019
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• Approved Label: 20 September 2019 (PDF)

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