ViroPharma Provides Update on V... ( EXTON Pa. Dec. 15 /- ViroPharma Incor...)

ViroPharma Provides Update on Vancocin(R)

Date:12/15/2008

EXTON, Pa., Dec. 15 /PRNewswire-FirstCall/ -- ViroPharma Incorporated (Nasdaq: VPHM) today provided the following update regarding Vancocin(R) (vancomycin hydrochloride capsules).

The Food and Drug Administration (FDA) has posted draft guidance for establishing bioequivalence (BE) to Vancocin. The new draft guidance is open for public comment, and if finalized as proposed would add new requirements for generic applicants beyond the in vitro dissolution testing originally proposed in March 2006. Under the draft guidance, generic applicants will also have to show that their products contain substantially the same inactive ingredients in substantially the same quantities as Vancocin. For generic versions of Vancocin that are not Ql and Q2 the same as Vancocin with respect to inactive ingredients, FDA is recommending in vivo BE studies with clinical endpoints in patients with Clostridium difficile.

Importantly, FDA has also called for public process specific to Vancocin, announcing that there will be a 60 day public comment period to review and comment on these draft guidance. FDA has acknowledged the complexity of the issues involved, and specifically stated that they will carefully consider such comments before responding to ViroPharma's Citizen Petition and finalizing BE recommendation for Vancocin.

Nowhere in the draft guidance does it indicate that FDA has correlated the described in vitro tests to an in vivo outcome, as required by FDA's regulation. A detailed description of this topic can be found at the following link (please cut and paste into your browser):

http://www.regulations.gov/fdmspublic/component/main?main=Document
'/>"/>

0

GOOD

Page: 1 2 3 4
Related medicine news :

1. ViroPharma to Present at the Maxim Group First Annual Growth Conference
2. ViroPharma to Present at the UBS Global Life Sciences Conference
3. ViroPharma Incorporated Reports Third Quarter and Nine-Month 2007 Financial Results
4. ViroPharma Receives European Orphan Drug Designation for CAMVIA(TM)
5. ViroPharma to Present at the 26th Annual JP Morgan Healthcare Conference
6. ViroPharma Augments Senior Management
7. ViroPharma Provides Update on Vancocin(R)
8. Vincent J. Milano to Succeed Michel de Rosen as President and Chief Executive Officer of ViroPharma
9. ViroPharma Incorporated Reports Fourth Quarter and Full Year 2007 Financial Results
10. ViroPharma Incorporated Reports First Quarter 2008 Financial Results
11. ViroPharma to Release 2008 Second Quarter Financial Results on July 30, 2008

Post Your Comments:

ViroPharma Provides Update on V...( EXTON Pa. Dec. 15 /- ViroPharma Incor...),Health