Drugs

Simulations Cut Generic Drug Development: FDA

FDA researchers have told an American Association of Pharmaceutical Scientists (AAPS) webinar that simulations based on branded drugs’ FDA-submitted data and limited use of a generic are adequate and can help shorten generic drug-device combination development timelines. An AAPS online post says the researchers described their work using an implantable contraceptive device as a way to prove that modeling can shorten generic development. They said the Office of Generic Drugs used data from FDA submissions for levonorgestrel (Bayer’s Mirena) to determine the adequate bioequivalence for a one-year test period.

The reference-listed drug was approved in 2000, AAPS says, but there still is no generic alternative despite the patent expiring in 2015. The product delivers a total of 52 mg of a contraception drug over a five-year period. The researchers said they hypothesized that if they removed an implant after a year to see how much levonorgestrel remained in the drug-carrying body, they would know how much product was delivered. And using a 90% confidence level, they could model how well a generic product needed to perform after one year to fall within the agency’s 80%-125% bioequivalence standard for generic applications.

The agency held a 10/2017 workshop on advancing the use of modeling and simulation to modernize generic drug development and regulation. During the AAPS webinar, FDA researchers said they wanted to limit questions and discussion to the science and not future policy or regulatory steps, and said they were interested in hearing from the scientific community about its work on modeling and simulation.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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