FDA Policy/General

Drug Marketing Warning Letter Sent to Vanthi

CDER’s Office of Prescription Drug Promotion (OPDP) has sent Vanthi (Newtown, PA) a Warning Letter objecting to a medical conference marketing panel for its Lomaira (phentermine hydrochloride USP) tablets. “This panel makes false or misleading claims and/or representations about the risks associated with Lomaira and omits material facts,” the OPDP letter says. The drug is indicated as a short-term (a few weeks) adjunct for weight reduction as part of a comprehensive treatment plan.

The panel makes several representations about the drugs benefits such as “THE POWER OF THREE” “Diet” “Exercise” “Lomaira” and it states “Consider adding Lomaira to your patients’ weight-management plan.” However, OPDP says, the panel is misleading because it fails to state that the drug is indicated for short-term adjunct use in a “regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity.”

The Warning Letter asks that the company stop misbranding the product with these or similar misleading claims.

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