This report identifies new Suitability Petitions filed, rejected and/or approved by the USFDA. The report includes the reason for Suitability Petition along with the USFDA document published on that Suitability Petition. 

Please find attached the report on list of drugs with Suitability Petitions activities for the month of September 2024 (filed / accepted / rejected / approved). The current month report covers the below products:

1. Bisoprolol Fumarate
2. Clonidine Hydrochloride
3. Ascorbic Acid
4. Fludrocortione Acetate
5. Dexamethasone
6. Cyclobenzaprine Hydrochloride

Please find attached the report on list of drugs with Suitability Petitions activities for the month of October 2024 (filed / accepted / rejected / approved). The current month report covers the below products:

Please find attached the report on list of drugs with Suitability Petitions activities for the month of September 2024 (filed / accepted / rejected / approved). The current month report covers the below products:

1.                  Cyproheptadine Hydrochloride

2.                  Amlodipine; Hydrochlorothiazide; Valsartan

3.                  Omeprazole and Sodium Bicarbonate

4.                  Triamcinolone Acetonide

5.                  Cisatracurium Besylate

6.                  Midodrine Hydrochloride

7.                  Dapsone

8.                  Lidocaine

9.                  Levothyroxine Sodium

10.             Bupivacaine Hydrochloride

11.             Levetiracetam In Sodium Chloride

12.             Vasopressin

13.             Metronidazole

14.             Hydromorphone Hydrochloride

This is a report on list of drugs with Suitability Petitions activities for the month of December 2024 (filed / accepted / rejected / approved). 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). 

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

1.                  Gabapentin

2.                  Nabumetone

3.                  Rimegepant

4.                  Binimetinib

5.                  Valacyclovir Hydrochloride

6.                  Hydrocortisone

7.                  Leucovorin Calcium

8.                  Estradiol

9.                  Diclofenac Potassium

10.             Bisoprolol Fumarate

11.             Clonidine Hydrochloride

12.             Fludrocortisone Acetate

13.             Nelarabine

14.             Apixaban

15.             Carbinoxamine Maleate

16.             Methimazole

17.             Baclofen

18.             Flurouracil

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

1. Linezolid
2. Potassium Acetate
3. Testosterone Enanthate
4. Hydrocortisone
5. Quetiapine Fumarate
6. Ceftriaxone
7. Spironolactone
8. Indomethacin
9. Ketorolac Tromethamine
10. Cyclobenzaprine Hydrochloride
11. Benazepril Hydrochloride
12. Piroxicam
13. Amlodipine Besylate, Hydrochlorothiazide, Valsartan
14. Benazepril Hydrochloride and Hydrochlorothiazide
15. Benazepril Hydrochloride
16. Lumateperone Tosylate
17. Hydrochlorothiazide
18. 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.

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.