Drugs

Lehigh Valley Tech Seeks Action Against Virtus Pharma

Lehigh Valley Technologies has petitioned FDA asking it to take enforcement action against Virtus Pharmaceuticals Holdings and to remove its unapproved drug products, mislabeled dietary supplements and medical foods from the market until Virtus complies with all regulatory requirements, including submitting data to FDA to demonstrate that the products pose no risk to public health and safety. Lehigh Valley says Virtus has neglected the quality of its products and over the past 10 month it has recalled seven products due to safety concerns.

The petition contends Virtus regularly misbrands its products. “Virtus not only misbrands unapproved prescription drugs as ‘dietary supplements,’ but Virtus also misbrands its dietary supplements and medical food products to look like prescription drugs by labeling them with sham National Drug Codes (NDCs) and the ‘Rx’ symbol,” it says. “For example, over the past year, Virtus acted in concert with its Canadian contract manufacturer to mischaracterize its potassium chloride powder for oral solution, a prescription drug product it sells in the United States, but imports from Canada as a ‘dietary supplement,’ in order to mislead U.S. Customs.”

Lehigh Valley asks FDA to inspect Virtus and its contract manufacturers to ensure compliance with current good manufacturing practices including compliant pharmacovigilance systems to timely manage and report complaints and adverse events. It also seeks the market removal of any of Virtus’s unapproved drugs, dietary supplements, or medical foods that pose a health and safety risk 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