Drugs

Bankrupt Akorn Recalls All Products

Akorn (Gurnee, IL) through its bankruptcy (Chapter 7) trustee is recalling various within-expiry human and animal products because the company has ceased all operations, including quality activities. In February, Akorn announced that it failed to find a buyer for its operations and terminated all employees (see letter).

“The discontinuation of the quality program means the company will not be able to support or guarantee that the products will meet all intended specifications through the labeled shelf life of the product,” the company said in a recall notice. “Further distribution or use of any remaining product on the market should cease immediately.”

In 9/2022, the Justice Department said Akorn had agreed to pay $7.9 million to resolve a whistleblower’s allegations that it caused Medicare to pay false claims by delaying its request to FDA to switch drugs from prescription to over-the-counter status. A department statement says Akorn caused Medicare Part D to pay for three generic drugs that were no longer eligible for Medicare coverage. As part of the settlement, it says, Akorn admitted that it continued to sell generic drugs under obsolete prescription-only labeling. The whistleblower received about $946,000 from the settlement proceeds, the statement said.

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