Drugs

Eugia Recalls 1 Lot of Acyclovir Sodium Injection

East Windsor, NJ-based Eugia U.S. (formerly AuroMedics Pharma) has recalled one lot of acyclovir sodium injection 500 mg per 10 mL single dose vials due to a product complaint about the presence of a dark red, brown and black particulate inside a vial. “The administration of an intravenous product containing particulates has the potential to result in inflammation, allergic reactions, or circulatory system complications which could be life-threatening,” a recall notice says. To date, the notice says Eugia has not received reports of any adverse events or identifiable safety concerns related to the lot. Acyclovir sodium injection is indicated for treating initial and recurrent mucosal and cutaneous herpes simplex in immunocompromised patients and initial clinical episodes of herpes genitalis in immuno-competent patients.

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