Suitability Petitions Report - May 2026

Greetings!

 Please find attached the report on the list of drugs with Suitability Petition activities for May 2026 (filed/accepted/rejected/approved). The current month's report covers the products below:

1. Acetazolamide

2. Apixaban

3. Trazodone Hydrochloride

4. Desloratadine

5. Prazosin Hydrochloride

6. Gabapentin

7. Naltrexone Hydrochloride

8. Tranexamic Acid

9. Gabapentin

10. Levetiracetam

11. Ibuprofen

12. Cyproheptadine Hydrochloride

13. Tramadol Hydrochloride and Acetaminophen

14. Triamcinolone Acetonide

15. Metformin Hydrochloride

16. Rosuvastatin Calcium

17. Ezetimibe And Simvastatin

18. Trazodone Hydrochloride

19. Clemastine Fumarate

20. Clemastine Fumarate

21. Dicyclomine Hydrochloride

22.Lisinopril Hydrochlorothiazide

23. Benazepril Hydrochloride; Hydrochlorothiazide

24. Dabrafenib Mesylate

25. Oxycodone Hydrochloride

26. Ivermectin

27. Buspirone Hydrochloride

28. Cyclobenzaprine Hydrochloride

29. Gabapentin

30. Cefixime

31. Mirtazapine

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.