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# GSK Submits Additional Zofran Study Info to FDA
- URL: https://www.fdaweb.com/gsk-submits-additional-zofran-study-info-to-fda/
- Published: 2020-05-27T12:00:00.000Z
- Updated: 2026-09-14T16:16:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146869

GlaxoSmithKline has submitted additional materials to FDA regarding the company’s 11/1/19 petition about four categories of information concerning the use of Zofran (ondansetron) in pregnancy. The 5/22 GSK [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2019-P-5151-0078&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) says that the company is aware that FDA and Novartis, the current Zofran NDA holder, may be reviewing the drug’s safety profile and labeling as a result of newly available epidemiological studies and an assessment of the drug’s labeling by the Pharmacovigilance Risk Assessment Committee.

The letter says that while the new studies and committee assessment are not part of the original GSK petition, the company has corresponded with the committee about its assessment and thus is submitting additional materials relating to that discussion to FDA.