Greetings!
Please find attached the report on list of drugs
with Suitability Petitions activities for the month of August 2025
(filed / accepted / rejected / approved). The current month report covers the
below products:
1. Atorvastatin calcium
2. Ranolazine
3. Metformin Hydrochloride
4.
Oxycodone Hydrochloride and Acetaminophen
5.
Spironolactone
6.
Ceftriaxone
7.
Quetiapine
8.
Tolmetin sodium
9.
Sulindac
10. Sodium Bicarbonate
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.