ViroPharma Inc. said Tuesday an upcoming Food and Drug Administration advisory committee meeting will focus on general generic drug issues and not specifically on the company's only marketed treatment, Vancocin.
Wall Street has been concerned that Vancocin, which treats gastrointestinal tract infections, could face generic competition in 2008, though several analysts say those concerns are lessening. The drug generated revenue of $49 million during the first quarter.
Vancocin is a biotech-based drug, which means it is made from living cells rather than a chemical process. The FDA does not yet have a system in place to test and approve generic versions of biotech drugs.
The advisory committee meeting for Pharmaceutical Science and Clinical Pharmacology is scheduled for July 23. ViroPharma said the FDA's Office of Generic Drugs will only present general issues about gastrointestinal condition treatments to the committee.
"Given ViroPharma's experience in this area, and the limited time available to speakers at the meeting, ViroPharma today submitted a letter to the Committee to aid its consideration of the general issue of bioequivalence methods for locally acting gastrointestinal drugs," the company said in as statement.
The FDA has indicated that ViroPharma can expect a later opportunity for public input on the issue, but has not yet committed to a next step, the company added.
The meeting is scheduled for July 23.
ViroPharma shares rose 20 cents to $11.03 in morning trading.
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