Suitability Petitions - June 2025

Please find attached the report on list of drugs with Suitability Petitions activities for the month of Jun 2025 (filed / accepted / rejected / approved). The current month report covers the below products:

1. Cyproheptadine Hydrochloride
2. Montelukast Sodium
3. Celecoxib
4. Abiraterone Acetate
5. Tadalafil
6. Maribavir
7. Dexchlorpheniramine Maleate
8. Capecitabine
9. Olaparib
10. Ivermectin
11. Meloxicam
12. Chlorzoxazone
13. Nabumetone
14. Binimetinib
15. Empagliflozin
16. Lumateperone
17. Lumateperone Tosylate
18. Sodium Polystyrene Sulfonate

About Suitability Petitions: A suitability petition is a request by an ANDA sponsor (called the “petitioner”) to submit an ANDA for a proposed generic drug that differs from the reference listed drug (RLD). Certain differences between a reference listed drug (RLD) and a proposed generic drug product may be permitted in an ANDA if these differences are the subject of an approved suitability petition submitted under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act.

Under GDUFA III, the FDA commits to addressing Suitability Petition issues. The commitment involves assigning goal dates, actively reviewing a percentage within specified time frames, and prioritising critical concerns like drug shortages, public health emergencies, waste reduction, or special reviews.