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# RVL Pharmaceuticals Wants Upneeq Equivalence Requirements
- URL: https://www.fdaweb.com/rvl-pharmaceuticals-wants-upneeq-equivalence-requirements/
- Published: 2021-06-08T12:00:00.000Z
- Updated: 2026-09-14T17:02:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149484

RVL Pharmaceuticals is petitioning FDA to require ANDA applicants and section 505(b)(2) applicants who seek “A” ratings to use appropriate methods to establish that their proposed products are bioequivalent and therapeutically equivalent to Upneeq (oxymetazoline HCl ophthalmic solution) 0/1%. The company’s 6/2 [petition](https://downloads.regulations.gov/FDA-2021-P-0533-0001/attachment%5F1.pdf?ref=fdaweb.com) asks the agency to take these specific actions: 

- require an ANDA for a proposed drug referencing Upneeq that is not qualitatively and quantitatively the same as Upneeq, or that differs in certain physicochemical properties, to include data from a comparative *in vivo* study with appropriate clinical efficacy and safety endpoints;
- require an ANDA for a drug product referencing Upneeq that is not qualitatively and quantitatively the same as Upneeq to include data from a comparative *in vivo* pharmacokinetic study;
- require an ANDA product referencing Upneeq to have the same labeling regarding child-resistant packaging as Upneeq;
- require an ANDA applicant to demonstrate that any proposed excipient that FDA previously has not approved for use in a human drug product at the proposed exposure level and for an ophthalmic route of administration is safe;
- issue a draft product-specific guidance that is consistent with the requests; and
- require specified actions from any sponsor of a 505(b)(2) application that references Upneeq.