Drugs

FDA Rejects Apiject's NDA for Glycopyrrolate Combination Product

FDA has issued a Complete Response Letter (CRL) to Apiject Systems Corp., declining to approve the company's NDA for a glycopyrrolate solution drug-device combination product, seeking an indication for use in adults as adjunctive therapy for treating peptic ulcers by reducing the amount of acid produced.The application, which was originally submitted on Sept. 25, 2025, was deemed not approvable because of unresolved deficiencies related to the quality, performance and safety of the combination product, according to the 7/21 rejection letter.

The CRL is the latest posted by the agency after it recently restarted the transparency initiative (see story) while it prepares a proposed rule to cement such postings. Much of the FDA's discussion of the deficiencies is redacted, but the agency divided its concerns into several broad categories, including the drug constituent of the combination product, the device constituent's performance and safety, human factors, and manufacturing. The letter also notes that amendments submitted by the company in June were acknowledged but not reviewed as part of the agency's action and may be incorporated into a future response.

In addition to addressing the product deficiencies, FDA instructed Apiject to provide updated safety information if the application is resubmitted, including new clinical safety data, revised adverse event tabulations, analyses of trial discontinuations, case narratives for serious adverse events and deaths, updated patient exposure data, worldwide postmarketing safety experience, and current foreign labeling. The agency characterized other comments in the letter as recommendations rather than approvability issues.

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