> ## 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 Withdraws NDA Approval of Bayer’s Baycol
- URL: https://www.fdaweb.com/fda-withdraws-nda-approval-of-bayers-baycol/
- Published: 2017-08-17T12:00:00.000Z
- Updated: 2026-09-14T22:41:57.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139414

*Federal Register* notice: FDA announces that at the company’s request it is withdrawing the approval of a Bayer NDA for Baycol (cerivastatin sodium) tablets, 0.05 milligrams (mg), 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, and 0.8 mg. The drug was approved in 1997 as an adjunct to diet for reducing elevated total and LDL cholesterol levels in certain patients. In 2001, Bayer stopped marketing the drug following reports associating cerivastatin with rhabdomyolysis, a potentially fatal condition involving muscle weakness. Subsequently, Bayer wrote FDA in 2014 asking the agency to withdraw the NDA’s approval. This notice completes the requested action. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2017-17510.pdf?ref=fdaweb.com).