Drugs

2 Charged for Misbranded Imported Drugs

The Justice Department says two men have been charged as part of its investigation into illegal importation and distribution of misbranded sildenafil, an active ingredient in FDA-approved erectile dysfunction drugs. A department statement says that Jitender Behl of East Greenwich, RI, imported hundreds of thousands of pills from India that contained sildenafil. He allegedly repackaged the pills and marketed them as JMY, an all-natural dietary supplement for erectile dysfunction. The ingredients listed for JMY did not include sildenafil but rather listed white willow bark and Korean ginseng, among others, the statement says.

Behl reportedly distributed the pills to Noor, Inc., a Providence, RI, wholesale distributor owned by Mahr Ahmed of Attleboro, MA. The statement says Ahmed has agreed to plead guilty to a charge of introducing misbranded drugs.

The department says that so far, law enforcement has seized more than 130,000 imported sildenafil pills and tablets, more than 650 grams of imported sildenafil soft gel capsules, and some 21,700 empty Mylar bags allegedly used to package the pills for distribution.

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