| Add to balance / Manage account | User: | Log out |
| Prospect News home > News index > List of issuers V > Headlines for ViroPharma Inc. > News item |
ViroPharma files petition for stay of action with FDA over generic drug changes
By Elaine Rigoli
Tampa, Fla., March 17 - ViroPharma, Inc. filed a petition for a stay of action in response to a Food and Drug Administration decision Friday that the company contends makes it easier for generic drug companies to make a version of Vancocin, an antibiotic intended to combat serious gastrointestinal (GI) disease.
ViroPharma said it expects to make additional filings in opposition to the FDA's decision.
ViroPharma said this action does not meet rigorous scientific methods to demonstrate a rate and extent of drug release to the site of action consistent with good medical and scientific practices, according to a company news release.
The company said it believes that, given the growing number of patients with severe, and possibly life-threatening, C. difficile-associated disease, the appropriate expert advisory groups must validate the scientific and medical appropriateness of the approval standards for a generic locally acting vancomycin capsule product.
ViroPharma had earlier commented that it had been informed that the FDA's Office of Generic Drugs, Center for Drug Evaluation and Research (OGD) may have changed its approach regarding the conditions that must be met in order for a generic drug applicant to request a waiver of in-vivo bioequivalence testing for Vancocin.
In a discussion with ViroPharma on Friday, OGD confirmed this change in approach, the company said.
C. difficile is a bacterium, which under certain circumstances, typically after antibiotic therapy, can colonize the lower GI tract where it may produce toxins that cause inflammation of the colon and diarrhea and the associated complications of disease, according to the release.
ViroPharma, a biopharmaceutical company located in Exton, Pa., develops products that address serious diseases treated by physician specialists and in hospital settings.
© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere.
For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.