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# Lymol Misses Postmarketing Milestone Date
- URL: https://www.fdaweb.com/lymol-misses-postmarketing-milestone-date/
- Published: 2019-02-05T12:00:00.000Z
- Updated: 2026-09-15T01:00:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143296

FDA says that Lymol Medical missed a milestone final report due date in the timetable for completion of a postmarketing requirement for sterile talc powder under its NDA. A 1/8 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630182.htm?ref=fdaweb.com) says the failure to comply without demonstrating a good cause for noncompliance violates the law and misbrands the product.

“This violation is concerning from a public health perspective,” the letter says, “because FDA is aware of lead content in sterile talc, and failure to conduct the postmarketing requirement impedes the evaluation of neurological, reproductive, developmental, immune, cardiovascular, and renal toxicities from lead exposure through use of sterile powder talc.”

FDA notified the company 2/5/18 of its requirement to perform a risk assessment study on the lead content of sterile talc powder and indicate any necessary controls on elemental impurities as shown in an International Council for Harmonization guidance.

The agency notified the company 8/9/18 that it had missed the final report submission date. Lymol failed to respond to that notification, the letter says. “Failure to promptly correct this violation may result in regulatory actions by FDA without further notice,” it says. “These actions include, but are not limited to, civil money penalties. Other federal agencies may take this Warning Letter into account when awarding contracts.”

The company was given 30 days to submit the final study report for its postmarketing requirement.