Watson Pharmaceuticals (NYSE:WPI) received approval from the U.S. Food and Drug Administration for its generic version of a drug to treat C. difficile.
Watson submitted an abbreviated new drug application for vancomycin hydrochloride capsules, USP, in 125 mg and 250 mg doses, used to treat diarrhea caused by C. difficile and for the treatment of enterocolitis, inflammation of the colon or small intestine. The drug is a generic version of ViroPharma‘s (NASDAQ:VPHM) drug Vancocin HCl.
The announcement prompted a statement from ViroPharma, an Exton, Pennsylvania biopharmaceutical company, that said it would file an injunction in District Court in the District of Columbia to suspend the FDA’s approval of three abbreviated new drug applications for its drug, despite a previous attempt that failed.
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ViroPharma had sought three additional years of exclusivity for the drug, but the agency denied the request and asserted that for an old antibiotic such as Vancocin to be eligible for a grant of exclusivity, it has to be for a significant new use or indication.
While the courts dismissed ViroPharma’s prior lawsuit on the procedural basis of standing, the company said the substance of its bioequivalence arguments and the arguments regarding Vancocin’s eligibility for exclusivity have not been litigated before the court.
In its statement, ViroPharma said that the “FDA is incorrect in interpreting its bioequivalence regulations in a manner that provides it with broad discretion to permit in vitro bioequivalence testing in the absence of a waiver of in vivo testing. ViroPharma believes that the FDA’s position is not supported by its regulations, or by FDA’s stated interpretation of those regulations at the time of their enactment.”
ViroPharma said the FDA’s move would be likely to dissuade manufacturers from these types of investments in better patient care with old antibiotics and is inconsistent with the statute and congressional intent for older antibiotics.
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ViroPharma in turn is facing an investigation by the Federal Trade Commission to assess whether it has engaged in unfair competition over Vancocin. The company said it intends to cooperate with the investigation.
The news spurred a dramatic plunge in the company’s share price, possibly because of an anticipated decline in sales of ViroPharma’s Vancocin with generic competition. As of 1:44pm, it had fallen 20 percent.
