Drugs

DoJ Wants Conspiracy Charge Against KVK-Tech

The Department of Justice (DoJ) has asked the 3rd Circuit Court of Appeals to reinstate conspiracy charges against KVK-Tech, a Newtown, PA, generic drug manufacturer. Courthouse News Service reports that in February 2022 a Pennsylvania federal court rejected the conspiracy charges, saying the government’s indictment failed to state an offense.

KVK is charged with distributing 383,000 bottles of hydroxyzine, an anxiety medication, between 2011 and 2013 that contained an active ingredient produced in a Dr. Reddy’s Laboratories facility in Mexico that was not FDA approved.

Attorneys for KVK said the company obtained the drug from an approved manufacturer with several operations in Europe that had contracted with the Mexican facility.

Government attorneys argued that FDA needs to know where a drug company is going to manufacture its ingredients and what the process is going to be. DoJ attorney Daniel Tenny said “the problem with what they did here was they got approval to do one thing, and they did a different thing.” He said that without FDA inspecting a manufacturing facility, the risk of a drug ingredient being adulterated is heightened.

The news service reports that the Dr. Reddy’s facility in Mexico was considered adulterated by FDA due to current good manufacturing practice violations. The agency had issued an alert to all the facility’s ingredient users from 7/2011 through 7/2012, it 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