Suitability Petitions: October 2025
Please find attached the report on list of drugs
with Suitability Petitions activities for the month of October 2025
(filed / accepted / rejected / approved). The current month report covers the
below products:
- Rizatriptan Benzoate
- Lactulose
- Diclofenac Sodium
- Pyridostigmine Bromide
- Buprenorphine
Hydrochloride
- Buprenorphine
Hydrochloride; Naloxone Hydrochloride
- Probenecid
- Enzalutamide
- Methylphenidate
Hydrochloride
- Flurbiprofen
- Liothyronine sodium
- Tizanidine
- Desloratadine
- Heparin Sodium
- Diclofenac Potassium
- Aripiprazole
- Hydrocortisone
- Testosterone enanthate
- Pregabalin
- Calcitriol
- Ganirelix Acetate
- Indomethacin
- Montelukast Sodium
- Paclitaxel
- Celecoxib
- Abiraterone Acetate
- Mirtazapine
- Buspirone 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.
