ViroPharma Provides Update on Vancocin(R)
Dec 15, 2008 13:53:00 (ET)
EXTON, Pa., Dec 15, 2008 /PRNewswire-FirstCall via COMTEX/ -- ViroPharma Incorporated (VPHM, Trade ) 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The Food and Drug Administration (FDA) has posted draft guidance for establishing bioequivalence (BE) to Vancocin. The new draft guidance is open for public comment, and if finalized as proposed would add new requirements for generic applicants beyond the in vitro dissolution testing originally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 Under the draft guidance, generic applicants will also have to show that their products contain substantially the same inactive ingredients in substantially the same quantities as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specific to Vancocin, announcing that there will be a 60 day public comment period to review and comment on these draft guidance.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Nowhere in the draft guidance does it indicate that FDA has correlated the described in vitro tests to an in vivo outcome, as required by FDA's regulation.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):
regulations.gov
"After several years, FDA has agreed with ViroPharma on the need for public process in the development of BE methods for Vancocin," commented Vincent Milano, ViroPharma's president and chief executive officer. "We will actively participate in this process to appropriately address this important public health issue with the ultimate goal of ensuring the safety of patients. For example, we will work to ensure that the process considers the potential severity of Clostridium difficile infections and its effect on a patient's GI tract, and that in vitro lab-based tests are correlated with in vivo outcomes to avoid any potential danger to patients who suffer from this life-threatening disease."
C. difficile is a bacterium, which under certain circumstances, typically after antibiotic therapy, can colonize the lower gastrointestinal tract where it may produce toxins which cause inflammation of the colon and diarrhea. Without proper treatment, the associated complications of the disease can be deadly. Advanced age, gastrointestinal surgery/manipulation, long length of stay in healthcare settings, a serious underlying illness and compromised immunity are conditions associated with increased risk of disease. According to the U.S. Centers for Disease Control and Prevention (CDC), there are an estimated 400,000 to 500,000 CA-CDAD and HA-CDAD cases annually based on 2004 data.
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