Drugs

OPDP Hits Triferic Web Page Promotion

CDER Office of Prescription Drug Promotion (OPDP) has sent Rockwell Medical an untitled letter after reviewing the company’s Triferic Web page and finding false and misleading information. The page is violative because it presents information about Triferic’s benefits but fails to include any risk information about the drug, the letter says. It also makes false or misleading claims or representations about the risks and efficacy associated with Triferic, and omits other material facts, it says. Triferic is an iron replacement product indicated for maintaining hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease.

“By omitting the risks associated with Triferic, the Web page fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the safety of Triferic,” FDA’s letter says. It also cites claims that suggest Triferic is safer and more effective than other iron replacement products, when this has not been demonstrated.

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