FDA Policy/General

FDA Authorizes 1st Generic Animal Drug for New World Screwworm

FDA has issued Felix Pharmaceuticals an Emergency Use Authorization (EUA) for generic nitenpyram tablets to treat New World screwworm (NWS) infestations in dogs and cats, marking the first generic animal drug authorized for use against the parasitic pest.

The authorization covers over-the-counter nitenpyram tablets for dogs, puppies, cats and kittens that are at least four weeks old and weigh at least two pounds. An FDA release says the treatment may be effective against NWS myiasis, a condition in which screwworm larvae infest living tissue.

The action is the latest step in the federal government's response to the expanding threat posed by New World screwworm, a flesh-eating parasite that lays eggs in open wounds and mucous membranes. After hatching, the larvae burrow into an animal's tissue, causing severe injury and potentially death if left untreated.

According to FDA, nitenpyram acts rapidly, killing most larvae within hours of administration. A second dose is recommended six hours after the first treatment. The drug does not prevent future infestations, and veterinary intervention may still be required to remove remaining larvae and manage wound care.

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