Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

ViroPharma Loses Challenge to Generic Drug Rule

By Pharmaceutical Processing | April 19, 2011

EXTON, Pa. (AP) — Shares of biopharmaceutical company
ViroPharma Inc. fell Monday after the company said a U.S. District Court ruled
against it in a challenge to an FDA decision.

The stock fell $2.14, or 9.8 percent, to close at $19.67.

In 2009, a Food and Drug Administration panel of experts
voted unanimously that generic drug companies should not have to conduct costly
human trials before launching generic versions of Vancocin, ViroPharma’s key
product. The drug is aimed at antibiotic-associated gastrointestinal infection.

ViroPharma had argued that generic drug companies seeking
approval to market generic versions of Vancocin should be required to conduct
testing in patients with gastrointestinal infections before making a generic
version.

ViroPharma had filed a motion with the U.S. District Court
of the District of Columbia
challenging the FDA on the matter, and that motion was dismissed on a basis of
“lack of standing,” according to a Securities and Exchange Commission
filing from ViroPharma.

The company said it is considering alternatives following
the decision.

During the fourth quarter of 2010, sales of Vancocin climbed
31 percent to $67.8 million. Sales of Cinryze, ViroPharma’s other drug, grew 49
percent to $52.5 million. Cinryze treats hereditary angioedema, a genetic
disease that can cause dangerous swelling in the throat and extremities.

 

Related Articles Read More >

Doctor, woman patient and tablet for consulting with results, medical info and talk for healthcare with mockup space. Japanese medic, digital touchscreen or show video for surgery, wellness or advice.
Putting patients first in clinical trials
Confidently navigate the transition from bench to batch
Merck
FDA approves Merck’s Winrevair to treat pulmonary arterial hypertension
kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2026 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE