Drugs

FDA Probe Leads to Charge Against Drug Importer

After an FDA Office of Criminal Investigations probe, federal prosecutors have charged a Hoover, AL man with receiving and reselling misbranded male enhancement drugs from China that could cause serious side effects in men taking medications containing nitrates. Nabil Chagri has been charged with one count of receiving and selling or offering to sell a misbranded prescription drug called Zhen Gong Fu because it did not declare that it contained sildenafil citrate, the active ingredient in Pfizer’s Viagra.

The Zhen Gong Fu labeling not only failed to disclose that the drug contained sildenafil, it also falsely and misleadingly stated that Zhen Gong Fu “does not affect heart diseases [sic], hypertension or diabetes,” according to a government release. The mislabeled drugs were mailed to Chagri from China at various addresses in Alabama, it says. “Between 3/2015 and 3/2016, FDA detained multiple packages containing the drugs in route from China to Chagri and issued eight import detention notices against him.”

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