Drugs

Apotex Recalls 3 Lots of Guanfacine Extended-Release Tablets

FDA says Apotex is recalling three lots of Guanfacine extended-release tablets 2 mg due to trace amounts of Quetiapine fumarate in one lot. A company announcement published by FDA says the administration of contaminated tablets can result in hypersensitivity reaction and may have additive effects in lowering blood pressure, sleepiness/sedation, and dizziness. Apotex says it has not received any reports of adverse events related to the recall.

Guanfacine is indicated for treating attention deficit hyperactivity disorder, the statement says, and can be used with other stimulant medications. Quetiapine is indicated for treating schizophrenia and other serious mental disorders.

The affected lots reportedly were distributed in the U.S. to wholesalers, distributors, warehousing chains, independent retail pharmacies, and retail buying groups.

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