Drugs

Injunction Entered Against Crown Laboratories

A Tennessee federal judge has entered a consent decree of permanent injunction against Crown Laboratories and its CEO to stop the distribution of unapproved and misbranded drugs. The Justice Department says the products include urea creams and lotions intended to treat a variety of skin ailments.

In a complaint sought by FDA, the Justice Department alleged that the defendants introduced unapproved and misbranded drugs into interstate commerce. Specifically, it said, the company sold a series of dermatological creams despite the absence of FDA approval or a sufficient showing that the products were safe and effective.

The injunction requires the company to stop manufacturing, selling, and introducing into interstate commerce any of its prescription and OTC creams and lotions. It cannot resume production until an application has been filed with FDA and approved by it. In addition, the company is to give the agency written notice that it is prepared to destroy all of its products.

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