Please
find attached the report on list of drugs with Suitability Petitions activities
for the month of May 2025 (filed / accepted / rejected / approved). The current
month report covers the below products:
1.
Paclitaxel
2.
Rizatriptan
Benzoate
3.
Tolmetin
4.
Montelukast
Sodium
5.
Irbesartan
6.
Cyproheptadine
Hydrochloride
7.
Flurbiprofen
8.
Indomethacin
9.
Carbidopa
And Levodopa
10.
Ganirelix
Acetate
11.
Calcitriol
12.
Ketorolac
Tromethamine
13.
Pregabalin
14.
Rivaroxaban
15.
Metronidazole
16.
Colestipol
Hydrochloride
17.
Hydrochlorothiazide
Oral Liquid
18.
Triamcinolone
Acetonide Gel
19.
Warfarin
Sodium
20.
Tizanidine
21.
Dicyclomine
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.