Dec. 20, 2019 – As 2019 comes to an end, the FDA’s Office of Prescription Drug Promotion issued its third Warning Letter of the year to Alkermes Inc. for a medication-assisted treatment drug print ad for Vivitrol® and followed that up with an unprecedented press release about the enforcement action on Dec. 11. OPDP also […]
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Sept. 8, 2017 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) has issued only two enforcement letters this year, its Aug. 24 Warning Letter to Cipher Pharmaceuticals followed a clear pattern: pursuing alleged omission of risk and omission of material facts. The letter to Cipher (ConZip Warning Letter), which licenses its ConZip® opioid […]
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