Drugs

Pfizer sNDA Approved for Pediatric-use Fragmin

FDA has approved a Pfizer sNDA for Fragmin (dalteparin sodium) subcutaneous injection to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients aged one month and older. VTE includes deep vein thrombosis and pulmonary embolisms, an agency release says. “Most children who have VTE are fighting a serious underlying primary illness such as cancer or congenital heart disease,” it says.

Fragmin was initially approved in 1994 for adults and is a type of heparin. Pediatric use approval was based on data from a single trial with 38 pediatric patients with symptomatic deep vein thrombosis or a pulmonary embolism. Patients were treated with Fragmin for up to three months, with starting doses by age and weight. “At study completion, 21 patients achieved resolution of the qualifying VTE, seven patients showed regression, two patients showed no change, no patients experienced progression of the VTE and one patient experienced recurrence of VTE,” the agency says.

The approval also requires a Boxed Warning to alert health care professionals and patients that epidural or spinal hematomas may occur in patients who are anticoagulated due to taking certain medications called low molecular weight heparins or heparinoids and are receiving neuraxial anesthesia (injection near the spine) or undergoing spinal puncture (removing spinal fluid for testing). The hematomas may result in long-term or permanent paralysis, FDA says.

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