Drugs

FDA Denies Generic Imodium Petition

FDA has denied an 11/2/2023 petition submitted by Hyman, Phelps & McNamara seeking permission to submit an ANDA for loperamide HCl capsules 1 mg and 4 mg, citing a reference to Johnson & Johnson’s Imodium capsules 2 mg. The agency’s 4/17 denial letter says that one of the requirements for a 505(j)(2)(C) petition is there is no NDA approved for the change sought in the petition. It says there already is an NDA approved for the 1 mg strength of loperamide HCl capsules, held by BionPharma.

The request for approval to submit a 4 mg dosage ANDA was likewise denied because the proposed change raises questions of safety that would require significant labeling changes to address the newly introduced safety problem posed by the proposed strength, which differs from the listed drug product, FDA says.

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