Cipher licensed ConZip to Vertical Pharmaceuticals for sale in the United States. The FDA’s letter cites issues with a promotional detail aid — such as a brochure or booklet — for the opioid, which does not communicate the potential risks associated with the medication.
“By omitting the risks associated with ConZip, including serious and potentially fatal risks, the detail aid fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug’s safety, a concern heightened by the serious public health impacts of opioid addiction, abuse and misuse,” said the FDA in the letter. “OPDP requests that Cipher immediately cease misbranding ConZip and/or cease introducing the misbranded drug into interstate commerce.”
The FDA letter instructed Cipher to respond to the agency on or before Sept. 8, regarding its intentions to comply with the order and its specific plans for discontinuing the use of the misleading promotional materials.
“Cipher takes all compliance matters very seriously and is currently working with Vertical to address the concerns identified,” Cipher said Thursday. “Vertical has informed Cipher that it has taken immediate corrective actions, including ceasing distribution of the ConZip promotional material cited in the warning letter, preparing a plan to collect and destroy the material, and commencing a corrective action communication to healthcare professionals.”
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CDC awards $28.6M to 44 states for opioid epidemic fight
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