> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Extends Review Date for Ascendis’ Lonapegsomatropin
- URL: https://www.fdaweb.com/fda-extends-review-date-for-ascendis-lonapegsomatropin/
- Published: 2021-06-15T12:00:00.000Z
- Updated: 2026-09-14T17:03:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149541

FDA has extended for three months to 9/25 the PDUFA review action date for the Ascendis Pharma BLA for lonapegsomatropin to treat pediatric growth hormone deficiency. The agency determined that information submitted by the company for FDA review constituted a major amendment, necessitating the additional review time. Company officials [say](https://investors.ascendispharma.com/news-releases/news-release-details/ascendis-pharma-announces-extension-us-food-and-drug?ref=fdaweb.com) they have responded to all outstanding FDA questions and believe the package they have submitted satisfies all of the agency’s requests and will enable a complete review of the BLA.