Drugs

FDA Alert on Compounding Remdesivir for Covid

FDA is urging drug compounders not to compound drug products using any remdesivir active pharmaceutical ingredient (API) due to its complex nature that makes it challenging to compound. “Remdesivir API is complex and neither a United States Pharmacopeia monograph nor other public quality standard for the API used in FDA-approved remdesivir is available,” an agency alert says. “Remdesivir API has six stereocenters and has multiple polymorphic forms,” it says. Using API forms that differ from the approved API may affect the compounded drug’s quality and solubility.

FDA 10/2020 approved a Gilead Sciences NDA for remdesivir, indicated for treating patients with Covid-19 that requires hospitalization. It previously was available in the U.S. under an emergency use authorization for treating hospitalized patients with severe Covid-19. The approval covers the use in adult and pediatric patients 12 years of age and older and weighing at least 88 pounds. Pediatric trials are ongoing, the agency says.

FDA’s alert also says it is aware of various entities (separate from the suppliers named in the approved remdesivir NDA) selling what they claim to be remdesivir API. “FDA often lacks detailed information about the composition and quality of the API that suppliers sell to compounders,” it adds.

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