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# Restrict ANDAs for Generic Xipere: Bausch & Lomb
- URL: https://www.fdaweb.com/restrict-andas-for-generic-xipere-bausch-lomb/
- Published: 2023-12-07T12:00:00.000Z
- Updated: 2026-09-14T14:18:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155942

A Bausch & Lomb FDA 11/30 citizen petition asks FDA to refuse to receive and/or refuse to approve any ANDA referencing Xipere (triamcinolone acetonide injectable suspension) that uses a different SCS injector than the approved proprietary SCS Microinjector unless the ANDA includes *in vivo* studies with clinical endpoints demonstrating that the product as a whole has the same safety and efficacy profile as Xipere. Xipere is indicated for suprachoroidal use to treat macular edema associated with uveitis.

The [petition](https://downloads.regulations.gov/FDA-2023-P-5343-0001/attachment%5F1.pdf?ref=fdaweb.com) also asks the agency to revise its 2/2023 draft product-specific guidance to require the same restriction and to include syringeability and glide force as physicochemical characteristics required for comparative purposes.

“Xipere was developed as a combination product such that the device component is as important to the safety and efficacy of the product as the drug component,” Bausch & Lomb says. “For that reason, it is critical that any proposed ANDA referencing Xipere have the same safety and efficacy profile as that of the SCS Microinjector used in Xipere….. Absent the same injector, the safety and efficacy of a generic version of Xipere should be demonstrated through *in vivo* studies and switching studies showing that the product can be used interchangeably with Xipere.”