CVM UNTITLED LETTERS.These letters are the regulatory activity letters issued by the Division of Epidemiology and Surveillance, Office of Surveillance and Compliance to makers of veterinary drugs. Copies are available from our RECORD-RETRIEVE service for $7 plus retrieval. 10613W Alpharma Animal Health, Ft. Lee, NJ, April 11 (CVM Division of Epidemiology and Surveillance). FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. cited Alpharma for lack of a distributor statement on file for an entity the name of which was purged. The letter noted that hexamitiasis, an infection of the gastro-intestinal tract by parasitic Hexamida meleagridis, was not among the cleared indications for the unnamed, tetracycline-based drug that was the subject of a new animal drug application (NADA). The letter was prompted by an annual drug experience report filed by Alpharma on Aug. 17, 2000. 10614W Merck & Co., Rahway, NJ, April 24 (CVM Division of Epidemiology and Surveillance). The letter stated that a labeling item for Heartgard Plus (ivermectin/pyrantel) compared the drug with milbemycin oxime oxime /ox·ime/ (ok´sem) any of a series of compounds containing the CH(dbondNOH) group, formed by the action of hydroxylamine upon an aldehyde or a ketone. ox·ime n. (MBO MBO See: Management buyout ) products and selamectin in treatment of canine parasites with zoonotic potential that may "call into question the efficacy" of MBOs in the treatment of Ancylostoma caninum. FDA insisted the comparison constituted "false or misleading representations" about the MBO products. The agency cited both the labeling and a print ad for lack of fair balance because they did not present risk associated with Heartgard Plus, including ataxia ataxia (ətăk`sēə), lack of coordination of the voluntary muscles resulting in irregular movements of the body. Ataxia can be brought on by an injury, infection, or degenerative disease of the central nervous system, e.g. and convulsions Convulsions Also termed seizures; a sudden violent contraction of a group of muscles. Mentioned in: Heat Disorders , "in the same scope, depth and detail" as benefits. F-B F-B Forward - Backward (radar image analysis) |
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