Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

ROCHE DIAZEPAM PETITION: FIVE STUDIES WILL BE CONDUCTED

Executive Summary

ROCHE DIAZEPAM PETITION: FIVE STUDIES WILL BE CONDUCTED to address the bioequivalence issues raised by the company in relation to generic diazepam, Roche outside counsel William Vodra (Arnold & Porter) told FDA in an April 9 letter. In February, Roche petitioned FDA to revise its bioequivalence requirements for generic versions of Valium to include pharmacodynamic studies of the availability of diazepam at the site of action. The firm further petitioned that FDA delay approvals of diazepam ANDAs and paper NDAs until adequate criteria for determining bioequivalence of diazepam products are established ("The Pink Sheet" March 4, p. 3). The five studies are: "A multiple dose steady state diazepam bioavailability study"; "bioavailability of two oral diazepam products in 24 subjects over 264 hours (Valium and Anksiyolin)"; "evaluation of receptor binding of Valium compared to two diazepam products in rodents"; "bioavailability following single oral doses of two diazepam products relative to Valium in patients with generalized anxiety disorder using both standard plasma levels and computer analyzed EEG measurements"; and "relative bioavailability of diazepam in normal volunteers following single oral doses of two diazepam products relative to Valium using both standard plasma levels and computer analyzed EEG measurements." The new studies were recommended to Roche by a group of 11 experts convened by Roche in early March to discuss the "pharmaco-EEG" study (by Itil, et al) of Valium which found a bioinequivalence problem with two generic diazepam products, Vodra explained. The members of the scientific panel included: George Simpson, MD, Medical College of Pennsylvania; Hank Yamamura, PhD, University of Arizona; Professor Rokus DeZeeuw, State University (Groningen, The Netherlands), David Greenblatt, MD, Tufts University; Bernard Cabana, PhD, President Internatl. Drug Registration, Steven Paul, MD, Natl. Institute of Medical Health. A "general consensus" agreed that the Itil study methodology and findings "were valid and more sensitive than conventional methods of bioavailability testing because [the study] assessed the drug effects on the target site of action," he continued. "Most importantly, the experts agreed that the data demonstrated bioinequivalence exists among the tested diazepam products, which could have serious clinical repercussions."

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

LL1132098

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel