The Federal Register

New Animal Drugs; Change of Sponsor; Chloramphenicol Capsules

Tue, Dec 20 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for a new animal drug application (NADA) for chloramphenicol capsules from Nylos Trading Co., Inc., to Pharmaceutical Ventures, Ltd.

Notice of Approval of Supplemental New Animal Drug Application; Tilmicosin

Tue, Dec 20 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice that it has approved a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The approved NADA provides for the veterinary prescription use of an injectable solution of tilmicosin phosphate for respiratory disease in cattle and sheep. This supplemental NADA adds user safety information to product labeling.

Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices)

Tue, Dec 20 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the following public meeting: Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices). The topics of discussion are the agency's activities regarding the regulation and approval of circulatory support devices used for temporary support in pediatric patients.

Date and Time: The public meeting will be held on January 20, 2006, from 9 a.m. to 12 p.m. The agency is requiring registration by December 30, 2005.

Location: The public meeting will be held at the Center for Devices and Radiological Health, rm. 20B, 9200 Corporate Blvd., Rockville, MD 20850.

Contact: Eric Chen, Center for Devices and Radiological Health (HFZ450), Food and Drug Administration, 9200 Corporate Blvd., 301443 8262, ext. 146, email: eac@cdrh.fda.gov, or Michael Berman (HFZ170), 12725 Twinbrook Pkwy., 3018274744, email: mrb@cdrh.fda.gov. If you nee