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# FDA to Decide on Calcitriol Manufacturer by 8/19
- URL: https://www.fdaweb.com/fda-to-decide-on-calcitriol-manufacturer-by-8-19/
- Published: 2018-05-08T12:00:00.000Z
- Updated: 2026-09-15T00:03:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141385

FDA has provided a target date of 8/19 for its response to a Rockwell Medical submission seeking approval of a new contract manufacturer for its approved generic drug Calcitriol vitamin D injection indicated for treating secondary hyperparathyroidism in dialysis patients. The agency indicated that the submission is getting an expedited review, Rockwell [says](http://ir.rockwellmed.com/news-releases/news-release-details/rockwell-medical-update-calcitriol-new-manufacturing-submission?ref=fdaweb.com). “The company is aware that FDA is conducting a pre-approval inspection of the contract manufacturing organization’s lab partner on 6/25,” Rockwell says.