Please find attached the report on list of drugs
with Suitability Petitions activities for the month of July 2025
(filed / accepted / rejected / approved). The current month report covers the
below products:
1. Fluoxetine
2. Zolpidem Tartrate
3. Metoprolol Tartrate
4. Pimozide
5. Tafamidis
6. Diclofenac Potassium
7. Testosterone Cypionate
8. Abiraterone Acetate
9. Sertraline Hydrochloride
10. Hydroxyzine Hydrochloride
11.
Valacyclovir Hydrochloride
12.
Ranolazine
13.
Cariprazine hydrochloride
14.
Meloxicam
15.
Gabapentin
16.
Rimegepant
17.
Hydrocortisone
18. Buspirone Hydrochloride
19. Nelarabine
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.