Drugs

All Companies Stopping Isoxsuprine Distribution

FDA says that as of 10/13, all manufacturers and labelers of isoxsuprine hydrochloride drug products agreed to cease distribution of the unapproved drugs. An agency online statement says that FDA announced on 7/15/20 a final decision of the commissioner that Vasodilan containing isoxsuprine HCl lacked substantial evidence, consisting of adequate and well-controlled studies, to be effective for specific indications.

According to WebMD, isoxsuprine HCl drugs were used along with other treatment for certain blood vessel diseases. They worked by widening blood vessels to help increase blood flow to certain parts of the body. The effect may help to decrease symptoms such as cold hands and feet, numbness, tingling, and decreased memory or judgment, it says.

FDA says it notified manufacturers and labelers of the products 8/9 to stop distributing their products.

The notice says the agency considers isoxsuprine HCl products to be unapproved new drugs that cannot be distributed in interstate commerce without an NDA approved by FDA.

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