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].