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Pharmaceuticals / Inspections and Audits

FDA Delivers CRL to Charleston Laboratories, Daiichi Sankyo for Opioid

Feb. 15, 2017

The FDA issued a complete response letter to Charleston Laboratories and Daiichi Sankyo, refusing to approve their NDA for CL-108, an opioid candidate which combines hydrocodone, acetaminophen and promethazine in a single pill.

In the letter, the agency said the NDA could not be approved in its current form, and provided the company with details on the information it needed to submit in order resolve the deficiencies in the application. The companies did not provide any additional information on the CRL.

CL-108 would be used to treat severe pain of the kind typically requiring opioid analgesics while reducing nausea and vomiting associated with opioid treatments.

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