Drugs

Petition Asks Trulance Labeling Additions

Hyman, Phelps & McNamara says that labeling for Synergy Pharmaceuticals’ Trulance (plecanatide), approved 1/19 to treat chronic idiopathis constipation in adults, fails to contain sufficient side effect information regarding diarrhea. In a citizen petition to FDA, the Washington-based law firm asks that Synergy be required to add additional statements.

“On the basis of publicly available information, we believe the approved Trulance PI fails to include adequate information for its use because it omits important safety information in its presentation of the incidence of diarrhea adverse events reported in clinical trials,” the petition says. “Specifically, the Trulance PI reports an incidence rate of diarrhea adverse events that is inaccurate without further characterization.”

The petition asks that FDA require Synergy to add a footnote stating that the actual rates of diarrheas in the Trulance clinical studies are higher and that the rates shown include only diarrhea reported to be bothersome or if the event required treatment or hospitalization.

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