FDA Policy/General

FDA Calls Xtampza ER Booth False, Misleading

The CDER Office of Prescription Drug Promotion (OPDP) says a Collegium Pharmaceutical exhibit booth for its Xtampza ER (oxycodone) extended-release capsules for oral use made false or misleading representations because it failed to adequately communicate information about the serious risks associated with the drug’s use. A 2/9 Notice of Violation says Xtampza ER is indicated for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate.

The drug labeling contains Boxed Warnings about addiction, abuse, misuse, life-threatening respiratory depression, accidental ingestion, neonatal opioid withdrawal syndrome, and risk from concomitant use with benzodiazepines or other central nervous system depressants.

The notice says that the OPDP advisory comments 9/9/16 addressed draft Collegium presentations for the drug with certain similarities to the exhibit booth. It says the booth made representations and/or suggestions about Xtampza ER but failed to adequately provide material information about the drug’s limitations of use and the serious and life-threatening consequences that may result from the use of the drug, thereby creating a misleading impression about the drug’s safety.

Collegium was told to stop using violative promotional materials and to respond with a list of all promotional materials containing statements such as those described in the notice and its plan for discontinuing such violative promotion.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome