Drugs

FDA Denies Petition on Colonoscopy Preparation

FDA has denied a Braintree citizen petition that asked it not to approve any NDA or ANDA for a tablet-based or tablet-containing colonoscopy preparation unless it contains a specification ensuring that the tablet formulation will not inhibit or interfere with the colonoscopy procedure. The petition said Braintree’s Sutab was developed using a formulation allowing for adequate visualization of the gastrointestinal tract. Approved in 2020, It is the first new tablet colonoscopy preparation to be approved by FDA since clinically challenged sodium phosphate tablets were first approved over two decades ago, according to the company.

Braintree argued that a formulation containing soluble ingredients requires a turbidity release specification to ensure the clinical performance of any tablet-containing colonoscopy preparation. “Sutab establishes a regulatory pathway for numerous potential new formulations that will rely on it as the reference-listed drug and inspire competitive development of tablet-based colonoscopy preparation products,” the petition concluded. “Therefore, it is imperative that an acceptable turbidity specification of dissolved tablets utilizing nephelometric specifications of no more than 20 nephelometric turbidity units (NTU) be established to not repeat the prior problems associated with tablet-based colonoscopy preparations. Future tablet-based colonoscopy preparations should, at a minimum, establish an in vitro methodology and specification for release prior to distribution not to exceed 20 NTU.”

In denying the petition, FDA said Braintree did not provide data to demonstrate that the in vitro turbidity test or its acceptance
criterion are correlated to Sutab’s in vivo performance. “Although the NDA for Sutab includes a turbidity test and acceptance criterion, the turbidity test and acceptance criterion were proposed by Braintree and were not required by the agency,” the agency said.

“Further,” FDA continued, “your petition has not established that the in vitro turbidity test or its acceptance criterion are necessary for other tablet-based colonoscopy preparation products. We are not persuaded that in vitro turbidity testing for future tablet-based colonoscopy preparation products would provide meaningful data regarding clinical outcomes or that such a test is necessary to ensure the safety and efficacy of the drug product.”

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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