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7 months ago
BRIEF-Charleston Laboratories and Daiichi Sankyo receive complete response letter from FDA for CL-108
February 3, 2017 / 5:38 PM / 7 months ago

BRIEF-Charleston Laboratories and Daiichi Sankyo receive complete response letter from FDA for CL-108

Feb 3 (Reuters) - Charleston Laboratories

* Charleston laboratories, inc. And daiichi sankyo, inc. Receive complete response letter from fda for new drug application for cl-108 (hydrocodone, acetaminophen, promethazine) tablets for oral use

* Charleston laboratories - crl stated nda in its present form was not approved and provided guidance on information needed to resolve matters identified Source text for Eikon: Further company coverage:

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