Opioid Warning Letter To Cipher Likely Easy Call For US FDA

 
• By Sue Sutter

Murky enforcement environment has probably contributed to FDA's record-low number of letters, but detailing material for ConZip failed to include risk information and important limitations of use for the tramadol extended-release product.

FDA entrance sign 2016
US FDA says Cipher's ConZip is misbranded by a violative sales detailing piece.

The US FDA Office of Prescription Drug Promotion's (OPDP) most recent enforcement letter – targeting marketing materials for a long-acting opioid that lacked any risk information – was probably an easy call for an agency whose leader has vowed it needs to be more forceful in responding to the opioid epidemic.

In an Aug. 24 warning letter, OPDP cited Cipher Pharmaceuticals Inc. for failing to include any risk...

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