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Summary of FDA Advertising and Promotion Enforcement Activity in 2015

January 2016, Covington Alert

This e-alert is part of a series of alerts summarizing publicly-available FDA enforcement letters relating to the advertising and promotion of prescription drugs, medical devices, and biologics. This alert reviews warning and untitled letters issued in 2015.

In 2015, FDA’s Office of Prescription Drug Promotion (OPDP) posted the following letters on FDA’s website:

  • Untitled letter to Luitpold Pharmaceuticals, Inc. re: Injectafer (ferric carboxymaltose injection) (January 29, 2015)
  • Untitled letter to Semel Institute for Neuroscience and Human Behavior re: [F-18] FDDNP (February 20, 2015)
  • Untitled letter to Discovery Laboratories, Inc. re: NDA 021746 SURFAXIN (lucinactant) Intratracheal Suspension (March 3, 2015)
  • Untitled letter to Otsuka Pharmaceutical Development & Commercialization, Inc. re: ABILIFY (aripiprazole) Tablets (April 17, 2015)
  • Untitled letter to Oak Pharmaceuticals, Inc. re: Nembutal Sodium Solution (pentobarbital sodium injection, USP) CII (May 15, 2015)
  • Untitled letter to Actavis Laboratories UT, Inc. re: Rapaflo (silodosin) Capsule for oral use (May 19, 2015)
  • Untitled letter to ASCEND Therapeutics US, LLC re: EstroGel 0.06% (estradiol gel) for topical use (June 23, 2015)
  • Warning letter to ECR Pharmaceuticals re: TussiCaps (hydrocodone polistirex and chlorpheniramine polistirex) Extended-release Capsules CII (July 27, 2015)
  • Warning letter to Duchesnay, Inc. re: DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets, for oral use (August 7, 2015)

The Office of Compliance and Biologics Quality (OCBQ) in FDA’s Center for Biologics Evaluation and Research (CBER) posted one letter in 2015, which Covington discussed in a previous alert.

The Office of Compliance (OC) in FDA’s Center for Devices and Radiological Health (CDRH) did not post any enforcement letters relating to advertising and promotion on FDA’s website in 2015.

This alert merely summarizes the allegations contained in FDA’s letters. It does not contain any analysis, opinions, characterizations, or conclusions by or of Covington & Burling LLP. As a result, the information presented herein does not necessarily reflect the views of Covington & Burling LLP or any of its clients.

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