Drugs

Purdue Wants Butrans Follow-on Restrictions

Purdue Pharma is asking FDA to ensure that follow-on products citing its Butrans (buprenorphine) transdermal system for transdermal administration as the reference-listed drug are as safe and effective as Butrans. The company’s petition specifically asks the agency to:

require that applications referencing Butrans contain appropriate toxicology and extractable leachable study data sufficient to evaluate any differences in the proposed formulations/products; and
require that any proposed follow-on buprenorphine patch products incorporate a patch disposal system that has been shown to be as safe and effective as the Butrans patch-disposal unit through comparative extraction, senior use, and child resistant testing.

Purdue argues that Butrans’ safety was established, in part, through extensive preclinical and chemistry, manufacturing, and controls extractable leachable data tailored to the Butrans formulation and packaging components. It also says that the Butrans patch-disposal unit enhances the product’s safety by reducing the risk of accidental exposure to and intentional abuse of used patches. “Proposed generic versions of Butrans without disposal systems, or with disposal systems that have not been shown through comparative extraction, senior use, and child resistance testing to perform as well as the Butrans patch-disposal unit are not as safe as Butrans, cannot duplicate the Butrans labeling, and do not have the same performance characteristics, operating principles, and critical design attributes as Butrans,” it says. It also says that a proposed 505(b)(2) buprenorphine patch that lacks a disposal system or has one that does not perform as well as the Butrans system has an unfavorable risk/benefit profile and should not be approved.

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