For updated information on the status of ProHeart 6 please see FDA news - FDA Announces Limited Return of Heartworm Drug to U.S. Market
January 31, 2005
DoubleTree Hotel
Rockville, MD
The FDA Veterinary Medical Advisory Committee (VMAC) will meet to discuss and make recommendations regarding the voluntary recall of the veterinary drug product ProHeart 6 ® and the Center's risk management strategy.
Information concerning the issues of the voluntary recall of ProHeart 6 ® (NADA 141-189) manufactured by Fort Dodge Animal Health will be made publicly available to the VMAC members and the public in advance of the meeting and posted on the Center for Veterinary Medicine's Home Page.
The meeting will be held on January 31, 2005, from 8:00 a.m. to 5:30 p.m., at the DoubleTree Hotel, Plaza Rooms II and III, 1750 Rockville Pike, Rockville, MD 20852 . The meeting will be open to the public. Interested persons may present data, information, or views, orally or in writing, on the issues pending before the committee. The point of contact for the meeting is Ms. Aleta Sindelar, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855.
CVM Updates
VMAC Meeting on ProHeart 6 ® Scheduled for January 31, 2005, January 14, 2005
Federal Register Notices
OC 20054. Veterinary Medicine Advisory Committee; Notice of Meeting. Page 3046 [FR Doc. 05-956] | htm | | pdf | Meeting on January 31, 2005
Voluntary Recall of ProHeart 6 ® (NADA 141-189)
Background Materials
VMAC Questions
Based on the presentations and information provided is ProHeart6 safe for use in dogs?
If there are remaining safety concersn with ProHeart6, what additional avenues of research could be explored to mitigate and/or prevent the adverse events?
Members and Consultants
VMAC Winter 2005 Transcript - January 31, 2005 | doc | | pdf |
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