Drugs

FDA Generic Drug Activities Reports

FDA says there were 10 section 505(j) ANDAs subject to priority review approved in the second quarter of FY 2021 (January-March) and six approved in the first quarter (October-December). A report, required under the FDA Reauthorization Act of 2017, also shows 58 awaiting FDA action in the second quarter. That’s up from 54 in the first quarter (October-December). And it shows there were 19 such ANDAs awaiting applicant action in the second quarter and 18 in the first quarter.

For FY 2021 ANDAs with a competitive generic therapy designation, there were 129 awaiting agency action in the second quarter, up from 114 in the first quarter. The number of ANDAs awaiting applicant action was 55 in the second quarter and 53 in the first quarter. There were 15 such ANDAs approved in the second quarter and 14 in the first quarter.

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