Drugs

Braintree Wants Restrictions on Tablet Colonoscopy Prep

Braintree is petitioning FDA not to approve under sections 505(b) and 505(j) of the Federal Food, Drug, and Cosmetic Act 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, which requires optical visualization of the colon. The petition says Braintree’s Sutab was developed using a formulation allowing for adequate visualization of the gastrointestinal tract. It is the first new tablet colonoscopy preparation to be approved by FDA since clinically challenged sodium phosphate tablets were first approved 21 years ago, it says.

The company says it believes that a formulation containing soluble ingredients and requiring a turbidity release specification is necessary 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 concludes. “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.”

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