Drugs

FDA OKs Neffy Allergic Reaction Nasal Spray

FDA has approved an ARS Pharmaceuticals NDA for neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including anaphylaxis, in adult and pediatric patients. “Today's approval provides the first epinephrine product for the treatment of anaphylaxis that is not administered by injection,” CDER Division of Pulmonology, Allergy and Critical Care associate director Kelly Stone is quoted in a release as saying. “Anaphylaxis is life-threatening and some people, particularly children, may delay or avoid treatment due to fear of injections.”

Neffy's approval was based on data from four studies in 175 healthy adults, without anaphylaxis, that measured the epinephrine concentrations in the blood following administration of neffy or approved epinephrine injection products, the agency says. “Results from these studies showed comparable epinephrine blood concentrations between neffy and approved epinephrine injection products,” it says. “Neffy also demonstrated similar increases in blood pressure and heart rate as epinephrine injection products, two critical effects of epinephrine in the treatment of anaphylaxis.”

FDA notes that neffy includes a warning that certain nasal conditions, such as nasal polyps or previous nasal surgeries, may affect the drug’s efficacy. It adds that patients with these conditions should talk to their physician to consider using neffy.

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