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# Rayner Wants Generic Omidria Restrictions
- URL: https://www.fdaweb.com/rayner-wants-generic-omidria-restrictions/
- Published: 2024-12-05T12:00:00.000Z
- Updated: 2026-09-14T14:48:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158312

Rayner Surgical is petitioning FDA to apply specified restrictions on any ANDA referencing or relying on Omidria (phenylephrine and ketorolac injection) 1%/3%. The 11/27 [petition](ttps://downloads.regulations.gov/FDA-2024-P-5569-0001/attachment%5F1.pdf) specifically asks that the agency:

- decline to accept or approve any ANDA referencing Omidria for a proposed generic product that lacks a buffer;
- decline to accept or approve any ANDA referencing Omidria for a proposed generic product that is not comparable to Omidria in pH, buffer capacity, and stability against oxidative degradation;
- if a proposed generic product referencing Omidria is allowed to deviate from Omidria’s formulation or differ in key physicochemical properties, FDA should require the ANDA to demonstrate bioequivalence through a suitably powered *in vivo* clinical endpoint study; and
- issue a product-specific guidance that is consistent with the company requests.

The petition says Omidria, which is a sterile aqueous solution, is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and for associated post-operative care. It says the drug’s formulation plays a key role in ensuring the product’s safety and efficacy