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# ‘Refusal to File’ Letter for Novo Nordisk Semaglutide
- URL: https://www.fdaweb.com/refusal-to-file-letter-for-novo-nordisk-semaglutide/
- Published: 2021-03-24T12:00:00.000Z
- Updated: 2026-09-14T16:52:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148952

FDA has issued a refusal to file letter for Novo Nordisk’s 1/20 label expansion application for once-weekly semaglutide 2.0 mg to treat Type 2 diabetes. The company [says](http://www.globenewswire.com/news-release/2021/03/22/2197266/0/en/Novo-Nordisk-receives-Refusal-to-File-letter-for-once-weekly-semaglutide-2-0-mg-for-the-treatment-of-type-2-diabetes.html?ref=fdaweb.com) the agency requested additional information including data relating to a proposed new manufacturing site. “While additional information needs to be included in the resubmission,” it says, “Novo Nordisk believes the already completed clinical trial program will be sufficient for approval of the label expansion application. Novo Nordisk expects to resubmit the application to FDA during the second quarter of 2021.”