Drugs

Recall 2 Acetazolamide Lots: University Petition

A 9/30 University of Kentucky petition asks FDA to recall one lot of acetazolamide manufactured by Mylan in India and one lot manufactured by Hikma in Portugal, due to insufficient active ingredient and/or increased impurities. A university news release says the Drug Quality Study at the UK HealthCare Pharmacy found that some samples had more than four times the FDA acceptable level of impurities.

Acetazolamide is an injectable diuretic available as a generic drug that is commonly used to treat glaucoma, epilepsy, altitude sickness, and fluid retention.

The university says its test results were confirmed by AMRI, a global contract research and manufacturing organization and an independent third party, which found that the samples of Mylan’s product contained 80% to 87% of the active pharmaceutical ingredient.

The release says UK HealthCare is not aware of any unexpected adverse effects in patients administered the drug.

In addition to seeking recall of the two lots, the petition requests examinations and investigation of acetazolamide and its manufacturing process, and that FDA provide information about the product to the public.

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

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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