BROMFENAC SODIUM | N021664 | BAUSCH AND LOMB INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition Amendment from Pharmobedient Consulting to FDA CDER FDA-2023-P-4359 Pharmobedient Consulting, LLC filed an amendment to a suitability petition with FDA CDER on October 18, 2023, for Bromfenac Ophthalmic Solution, 0.08%, providing reference listed drug labeling information for the RLD under NDA N021664 (BROMDAY and XIBROM products) as requested by the agency pursuant | Suitability | 2023-10-19 | Open | — |
Attachment 4 - Draft Guidance on Bromfenac Sodium RE Suitability Petition fro... FDA-2023-P-4359 Pharmobedient Consulting, LLC filed a petition regarding bromfenac sodium requesting FDA guidance on the suitability of the drug substance for use in abbreviated new drug applications (ANDAs), specifically addressing regulatory reference eligibility and quality standards. | Suitability | 2023-10-05 | Open | Pharmobedient Consulting |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2023-P-4359 Pharmobedient Consulting, LLC submitted a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Bromfenac Solution/Drops, 0.08% suitable for submission in an Abbreviated New Drug Application, representing a strength change from th | Suitability | 2023-10-05 | Open | Pharmobedient Consulting |
Citizen Petition from ISTA Pharmaceuticals, Inc., (Covington & Burling LLP) FDA-2010-P-0625 ISTA Pharmaceuticals, Inc. filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that FDA consider that bromfenac ophthalmic solution 0.09% with once-daily dosing (BROMDAY) is safer than the higher twice-daily dose formulation (XIBROM) and should be | 505(q) Stay Request | 2011-02-15 | Withdrawn | ISTA Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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