Drugs

Rescind Voltaren OTC Approval: Petition

A 3/30 Wiley Rein petition asks FDA to withdraw or rescind its 2/14 approval of a supplemental NDA switching GlaxoSmithKline’s Voltaren Arthritis Pain (diclofenac sodium) topical gel 1% from Rx only to over-the-counter status. The petition says the OTC switch should be rescinded because “important safety information contained in the previously-approved prescription labeling of diclofenac topical gel 1% is not adequately reflected in the OTC labeling approved on 2/14.”

The petition lists seven sections of the initial labeling that the firm says fail to appear, in a manner appropriate for consumer understanding, in the OTC labeling.

“In each case, the petitioner requests specific revisions be made to any approved OTC labeling should the agency, upon reexamination, conclude that diclofenac gel 1% is still an appropriate product to be sold over the counter,” the petition says. “The petitioner, however, defers to the agency regarding the precise language of any revision and the most appropriate label placement of the revision.”

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