Drugs

FDA Approves Heron’s Sustol for Treating Nausea

FDA has approved a Heron Therapeutics for Sustol (granisetron) extended-release injection, a serotonin-3 (5-HT3) receptor antagonist indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide combination chemotherapy regimens. The product uses Heron’s Biochronomer polymer-based drug delivery technology to maintain therapeutic levels of granisetron for five days and longer, covering both the acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV).

The approval was more than three years in the making. In 3/2013, FDA issued a complete response letter for the drug, asking that the company refine a chemistry, manufacturing and controls product quality analytical test method, and address deficiencies identified during facility pre-approval inspections (see story).

The NDA included data from the MAGIC study, Heron’s multi-center, placebo-controlled, Phase 3 study involving more than 900 patients receiving highly emetogenic chemotherapy regimens. Data from an earlier Phase 3 study of more than 1,300 patients, which were previously submitted to the agency, demonstrated Sustol’s efficacy in preventing acute and delayed CINV associated with MEC regimens and acute CINV associated with HEC regimens, the company 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