Drugs

FDA OKs Updated Temodar Indications

FDA has approved updated labeling for Merck’s Temodar (temozolomide) under Project Renewal, an Oncology Center of Excellence program to update labeling information for older oncology drugs to ensure the information is clinically meaningful and scientifically up-to-date. An agency statement says it is the second drug to receive an updated label under the pilot program.

With the update, FDA says, Temodar is approved for these new and revised indications:

adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma, and
treatment of adults with refractory anaplastic astrocytoma.

An approved indication that remains the same is for treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment, the notice says.

Other labeling revisions are:

a revised and updated dosage regimen for newly diagnosed glioblastoma and refractory anaplastic astrocytoma;
the addition under Warnings and Precautions of information on risks from exposure to opened Temodar capsules; and
an updated and revised labeling section on patient counseling information and the patient information document.

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