FDA rejects new drug application from Jupiter biotech firm


The United States Food and Drug Administration last week rejected a new drug application filed by Jupiter’s Charleston Laboratories and partner Daiichi Sankyo, based in Japan.

The drug; a combination of hydrocodone, acetaminophen, promethazine currently called CL-108; was not approved in its present form, according to a “complete response letter” from the FDA, which also offered guidance on information needed to approve the substance, aimed at treating severe pain while preventing or reducing opioid-induced nausea and vomiting.