Philadelphia Business Journal by John George, Senior Reporter
ViroPharma Inc. said it has received a notification that the Federal Trade Commission is conducting an investigation into whether the company has engaged in unfair methods of competition with respect to its antibiotic product Vancocin.
“The existence of an investigation does not indicate that the FTC has concluded that ViroPharma has violated the law and the company does not believe that it has engaged in unfair methods of competition,” ViroPharma (NASDAQ:VPHM) officials said in a statement
The Exton, Pa., biopharmaceutical company said it intends to cooperate with the investigation.
Word of the FTC probe comes at the same time the Food and Drug Administration approved three companies’ applications to market a generic for Vancocin. The FDA also on Tuesday denied ViroPharma’s petition seeking to block the agency method’s for evaluating generic competitors and ruled the company is not entitled to three additional years of market exclusivity after filing a supplemental new drug application for Vancocin.
ViroPharma said it believes the FDA violated its own regulations by allowing generic drug companies to submit the results of in vitro (test tube) bioequivalence testing without requiring a waiver for in vivo (human) testing.
Vancocin is used to treat a common and potentially life-threatening hospital-acquired infection known as clostridium difficile-associated pseudomembranous colitis, also known as C-diff.
ViroPharma’s stock price plunged 22 percent Tuesday, closing at $22.44 per share.