Original New Drug Application Approvals by US FDA (01-15 February 2024)

New drug applications approved by US FDA as of 01-15 February 2024 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.

EOHILIA

• Active Ingredient(s): Budesonide
• Strength: 2MG/10ML
• Dosage Form(s) / Route(s): Suspension;oral
• Company: Takeda Pharms Usa
• Approval Date: 09 February 2024
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for 12 weeks of treatment in adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EoE).
  Limitations of Use EOHILIA has not been shown to be safe and effective for the treatment of EoE for longer than 12 weeks.
• Approved Label:  09 February 2024 (PDF)

LEGUBETI

• Active Ingredient(s): Acetylcysteine
• Strength: 500MG,2.5GRAMS
• Dosage Form(s) / Route(s): Solution;oral
• Company: Galephar Pharmaceutical Research Inc.
• Approval Date: 13 February 2024
• Submission Classification: Type 2 - New Active Ingredient and Type 3 - New Dosage Form
• Indication(s): indicated as an antidote to prevent or lessen hepatic injury, which may occur following the ingestion of a potentially hepatotoxic quantity of acetaminophen, in adults and pediatric patients. It is essential to initiate treatment as soon as possible after the overdose and, in any case, within 24 hours of acetaminophen ingestion.
• Approved Label:  13 February 2024 (PDF)

AURLUMYN

• Active Ingredient(s): Iloprost
• Strength: 100MCG/ML
• Dosage Form(s) / Route(s): Solution;injection
• Company: Eicos Sciences, Inc.
• Approval Date: 13 February 2024
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations. Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes.
• Approved Label:  13 February 2024 (PDF)

PANTOPRAZOLE SODIUM

• Active Ingredient(s): Pantoprazole Sodium
• Strength: 40MG/100ML (0.4MG/ML),80MG/100ML (0.8MG/ML)
• Dosage Form(s) / Route(s): Injectable;intravenous
• Company: Baxter Hlthcare
• Approval Date: 14 February 2024
• Submission Classification: Type 3 - New Dosage Form
• Indication(s): Indicated in adults for the following:
  • Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of erosive esophagitis (EE).
  • Pathological hypersecretion conditions including Zollinger-Ellison(ZE) Syndrome.
• Approved Label:  14 February 2024 (PDF)