505b2 approvals of Q1 2024

505b2 approvals of Q1 2024

Wondering what value additions 505b2 bring and how companies solve the unmet need. Look at below recent approvals of Q1 2024 to know more:


1. EOHILIA (Budesonide), Oral solution
Approval: Feb 09, 2024
Applicant: Takeda
Indication: For eosinophilic esophagitis (EoE)
Value addition: First and only FDA-approved oral therapy for people 11 years and older with eosinophilic esophagitis (EoE).


2. LEGUBETI (Acetylcysteine lysine), For oral solution
Approval: Feb 13, 2024
Applicant: Galephar Pharma
Indication: To prevent or lessen hepatic injury because of excess acetaminophen ingestion
Value addition: Different salt with high water solubility


3. AURLUMYN (Iloprost), IV solution
Approval: Feb 13, 2024
Applicant: Eicos Sci
Indication: Treatment of severe frostbite
Value addition: First-ever treatment option for severe frostbite indication


4. PANTOPRAZOLE SODIUM IN 0.9% NaCl, IV solution
Approval: Feb 14, 2024
Applicant: Baxter
Indication: Gastroesophageal Reflux Disease & Zollinger-Ellison Syndrome
Value addition: Ready to use premixed sterile solution packaged in a single-dose GALAXY container.


5. SEHIPPY (Vortioxetine), ODT
Approval: Feb 16, 2024
Applicant: Seasons Biotechnology Co Ltd
Indication: Major depressive disorder
Value addition: For patients with dysphagia (Swallowing difficulty)


6. CLOBETASOL PROPIONATE, Ophthalmic drops
Approval: Mar 04, 2024
Applicant: Formosa
Indication: Post-operative inflammation and pain following ocular surgery
Value addition: Convenient dosing regimen – twice daily without titration. Based on APNT™ formulation platform (particle size reduction).


7. TALZENNA (Talazoparib), Oral capsule
Approval: Mar 07, 2024
Applicant: Pfizer
Indication: Breast cancer & Prostate cancer
Value addition: New formulation


8. CABAZITAXEL, IV solution
Approval: Mar 14, 2024
Applicant: Actavis
Indication: Castration-resistant prostate cancer
Value addition: New strength formulation which avoids first dilution step


9. EDURANT PED (Rilpivirine), Tablet for oral suspension
Approval: Mar 15, 2024
Applicant: Janssen
Indication: HIV1 infection 2 years of age and older
Value addition: Developed to aid administration and weight-adjusted dosing for children


10. OPSYNVI (Macitentan & Tadalafil), Oral tablet
Approval: Mar 22, 2024
Applicant: Actelion
Indication: Pulmonary arterial hypertension (PAH)
Value addition: First and only once-daily single-tablet combination therapy


11. RISVAN (Risperidone), Extended release powder for IM administration
Approval: Mar 29, 2024
Applicant: Labs Farm Rovi SA
Indication: Schizophrenia
Value addition: First injection which provides immediate and sustained plasma drug levels and does not require loading doses or supplementation with oral risperidone [based on in situ microparticles (ISM) delivery technology].


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