Drugs

Consent Decree Against LGM Pharma

The U.S. District Court for Southern Florida 1/20 entered a consent decree of permanent injunction against LGM Pharma and two of the company's executives, CEO Prasad Raje and quality and regulatory affairs senior vice president Shailesh Vengurlekar, to bring the company into CGMP compliance. LGM introduced into interstate commerce adulterated drugs that were manufactured, processed, packed or held in conditions that do not comply with CGMP requirements under the FD&C Act., FDA says.

The agency’s 1/11 complaint says LGM imports and distributes drugs, including active pharmaceutical ingredients, from a facility in Erlanger, KY. FDA inspected the headquarters and Kentucky facilities in 3/2022 and 4/2022, it says, and found multiple instances in which the defendants failed to adhere to current good manufacturing practice regulations for receiving, holding, and distributing drugs. The agency says many of the violations seen in the 2022 inspection were similar to inspection observations in a 2018 inspection.

The consent decree requires ongoing compliance auditing and reporting to FDA, and also allows the agency to take appropriate action, including ordering the company to cease receiving, labeling, holding and/or distributing any or all drug substances, if the defendants further violate the FD&C Act or the consent decree.

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