XIBROM

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

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

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.

FDA-2015-P-2962

Regcon Solutions LLC filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA amend the Orange Book to designate Hi-Tech Pharmacal's Bromfenac Sodium ophthalmic solution 0.09% acid (ANDA 203395) as a second reference listed drug, since the

FDA-2011-P-0128

ISTA Pharmaceuticals, Inc. filed this citizen petition under 21 C.F.R. § 10.30 to request that the FDA refrain from granting tentative or final approval of any ANDA for bromfenac ophthalmic solution 0.09% that uses the discontinued XIBROM labeling with twice-daily dosing or omits the once-daily dosi

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