October 15, 2013

 

 Drug approvals voluntarily withdrawn

 
The Food and Drug Administration announced it was withdrawing approvals for use of six antimicrobial drugs in livestock feed and one drug to prevent heartworm disease in dogs.
 
The agency said in two notices in the Aug. 23 Federal Register that the drug sponsors no longer made or sold the affected products.
 
The agency indicated that Phibro Animal Health had requested the withdrawal of two combination medicated feed products, both of which contain nicarbazin and penicillin and one of which also contains roxarsone. A separate agency announcement stated that those drugs had been approved more than 40 years ago.
 
Quali-Tech Products also requested that the agency withdraw approval of Quali-Tech Tylan-10, a tylosin phosphate drug; Q.T. Ban-Tech, a pyrantel tartratel drug; Flavomycin, a bambermycins drug; and Stafac, a virginiamycin drug, all of which the company no longer makes, according to another Federal Register notice.

R.P. Scherer North America also asked that the agency withdraw approval for diethylcarbamazine citrate capsules that are no longer made or sold for use in preventing heartworm disease in dogs, according to the Federal Register.