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 for stay of action with FDA for Vancocin capsules
By Lisa Kerner
Charlotte, N.C., June 30 - ViroPharma Inc. said it submitted a supplement to its Petition for Stay of Action with the Food and Drug Administration related to the bioequivalence requirements for abbreviated new drug applications that seek to copy Vancocin capsules.
The company claims the FDA's decision to modify the bioequivalence standards for generic copies of Vancocin capsules is scientifically flawed, according to a company news release.
ViroPharma maintains that anything less than an in vivo demonstration of bioequivalence in clostridium difficile-associated disease and enterocolitis caused by Staphylococcus aureus could put patients at risk.
Located in Exton, Pa., ViroPharma develops and commercializes products to treat viral diseases including cytomegalovirus and hepatitis C.
© 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.