Suitability Petitions: September 2025

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

1. Mycophenolate Mofetil
2. Ubrogepant
3. Ketamine Hydrochloride
4. Sertraline Hydrochloride
5. Methenamine Hippurate
6. Methimazole
7. Lactulose
8. Tizanidine
9. Cyclobenzaprine Hydrochloride
10. Linezolid
11. Indomethacin
12. Potassium Acetate
13. Ketorolac Tromethamine
14. Flurbiprofen
15. Tizanidine Hydrochloride

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.