Labeling Type
34391-3
Status
Approved
Full Title
{"br": [null, null, null], "footnote": "An interchangeable product (IP) is a biological product that is approved based on data demonstrating that it is highly similar to an FDA-approved reference product (RP) and that there are no clinically meaningful differences between the products; it can be expected to produce the same clinical result as the RP in any given patient; and if administered more than once to a patient, the risk in terms of safety or diminished efficacy from alternating or switching between use of the RP and IP is not greater than that from the RP without such alternation or switch. Interchangeability of REZVOGLAR has been demonstrated for the condition(s) of use, strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.", "#text": "These highlights do not include all the information needed to use REZVOGLAR safely and effectively. See full prescribing information for REZVOGLAR.REZVOGLAR (insulin glargine-aglr) injection, for subcutaneous useInitial U.S. Approval: 2021REZVOGLAR (insulin glargine-aglr) is interchangeable with LANTUS (insulin glargine)"}
United States
Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.