US FDA Suitability Petitions - Updates
July 28, 2025
At ISAZI, we believe timely and precise regulatory intelligence is critical to informed decision-making in pharmaceutical development.
As part of our commitment to staying current and sharing value with the life sciences community, we are pleased to announce a new initiative: regular updates on Suitability Petitions (SPs) posted on Regulations.gov.
📌 Suitability Petitions offer strategic insights into alternative dosage forms, strengths, or routes of administration of already approved drug products—knowledge that can open new pathways for 505(j) ANDAs or even 505(b)(2) applications.
🧠These brief SP summaries will:
Highlight emerging trends and opportunities
Support R&D and regulatory strategy planning
Reinforce our commitment to proactive, data-driven regulatory practices
Find below recent updates posted in last few weeks on Suitability Petitions. We look forward to supporting our clients in making informed regulatory decisions.
đź“© For more on how regulatory intelligence can drive innovation and compliance, connect with our team at ISAZI. Follow ISAZI page on LinkedIn to stay updated https://www.linkedin.com/company/weareisazi/posts/?feedView=all.
SP1. Additional Strength ANDA SP Approved
SP submitted by PharmEng Technology Inc
Proposed Product: Metronidazole Tablets USP, 50 mg.
Referred Listed Drug in SP: Flagyl (Metronidazole) Tablets USP, 500 mg (NDA# 012623).
Docket No. FDA-2009-P-0121
Final response Posted by FDA on May 21, 2025
SP2. Additional Strength ANDA SP Submitted
SP submitted by SENORES PHARMACEUTICALS, INC.
Proposed Product: Montelukast Sodium Chewable Tablets, 10 mg
Referred Listed Drug in SP: SINGULAIR (TABLET, CHEWABLE) 4 mg, and 5 mg (NDA# 020830)
Docket No. FDA-2025-P-1373
SP Posted date: May 22, 2025
SP3. RLD Product Withdrawn Reason SP Submitted
SP submitted by LGM Pharma
Referred Listed Drug in SP: Phenaphen w/ Codeine No. 3 and Phenaphen w/ Codeine No. 4 capsules (ANDA # A084445 and A084446)
Docket No. FDA-2025-P-1372
SP Posted date: May 22, 2025
SP4. RLD Product Withdrawn Reason SP Submitted
SP submitted by Amta Labs Limited
Referred Listed Drug in SP: Coreg CR (carvedilol phosphate) extendedrelease capsules, 10 milligrams (mg), 20 mg, 40 mg, and 80 mg
Docket No. FDA-2025-P-0101
SP Posted date: May 30, 2025
SP5. Additional Strength ANDA SP Submitted
SP submitted by Hyman, Phelps and McNamara, P.C.,
Proposed Product: Paclitaxel protein-bound particles for Injectable Suspension (albumin-bound) (“Paclitaxel for Injectable Suspension”) in a 200 mg/vial lyophilized powder
Referred Listed Drug in SP: Bristol Meyers Squibb’s Abraxane® (paclitaxel protein-bound particle) for Injectable Suspension, 100 mg, approved under NDA 021660.
Docket No. FDA-2025-P-1476-0001
SP6. Additional Strength ANDA SP Submitted
SP submitted by SENORES PHARMACEUTICALS, INC.,
Proposed Product: Tolmetin Capsules 600 mg
Referred Listed Drug in SP: TOLECTIN DS 400 mg from ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC, which FDA approved Prior to Jan 1, 1982 under NDA # N018084.
Docket No. FDA-2025-P-1454-0001
SP7. Additional Strength ANDA SP Submitted
SP submitted by SENORES PHARMACEUTICALS, INC.,
Proposed Product: Tolmetin Capsules 200mg
Referred Listed Drug in SP: TOLECTIN DS 400 mg from ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC, which FDA approved Prior to Jan 1, 1982 under NDA # N018084.
Docket No. FDA-2025-P-1452-0001
SP8. Additional Strength ANDA SP Submitted
SP submitted by Newcastle Bioscience LLC,
Proposed Product: Rizatriptan Benzoate Tablets 7.5 mg
Referred Listed Drug in SP: Maxalt (Rizatriptan Benzoate) Tablets 10 mg and 5 mg subject of NDA 020864.
Docket No. FDA-2025-P-1465-0001
SP9. RLD Product Withdrawn Reason SP Approved
SP submitted by Pharmobedient Consulting, LLC
Referred Listed Drug in SP: Actigall (ursodiol) capsule, 150 milligrams (mg), new drug application (NDA) 019594
Docket No. FDA-2025-P-0184
SP Posted date: May 30, 2025
SP10. Dosage form change SP Denied
SP submitted by Hyman, Phelps & McNamara, P.C
Proposed Product: Triamcinolone Acetonide Gel, 0.1%
Listed Drug in SP: Triamcinolone Acetonide Cream, 0.1% approved under ANDA 085692 and held by Fougera Pharmaceuticals Inc.
Docket No. FDA-2025-P-0184
SP Posted date: May 28, 2025