FDA Policy/General

First Heartworm Generic Drug for Dogs Approved

FDA announced 2/17 the approval of Maryland Heights, MO-based Anzac Animal Health’s Diroban (melarsomine dihydrochloride), the first generic drug to treat heartworm disease in dogs. An agency news release said the drug is administered by deep injection into the back muscles. It is used to treat dogs with stabilized class 1 (no symptoms), class 2 (mild to moderate respiratory symptoms), and class 3 (severe respiratory symptoms) heartworm disease. It should not be used in dogs with class 4 (extremely severe respiratory symptoms) heartworm disease.

Side effects may include pain, swelling, or tenderness at the injection site, coughing/gagging, decrease in activity level, lack of appetite, fever, and vomiting, the agency said. Heartworm disease is caused by a thread-like parasitic worm called Dirofilaria immitis that lives in the heart, lungs, and associated blood vessels of an infected animal. “In dogs, the disease results in heart failure, severe lung disease, other organ damage, and death,” the release says. “Heartworm disease is only spread through the bite of a mosquito; it cannot be transmitted directly from one dog to another.”

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