Veterinary approval

These drugs are available as sodium salts. In general, they are expensive and their use in equine practice is limited. A veterinary approved formulation of ticarcillin is available in the USA for intrauterine administration to mares. 

Center for Veterinary Medicine (CVM). This center is responsible for the regulation and approval of animal food and dmg products. The center... 

The exact requirements for regulatory approval of a given product for veterinary purposes, whether prescription or over-the-counter, vary from country to country. Product development often takes a minimum of eight to ten years and usually requires large (> 10 x 10 ) sums of money. 

Note that some treatment operations choose a pollution prevention technique to dispose of the float. This involves feeding the float to animals. When this is done for the situation where the feed animals are used for human consumption, organic compounds such as chitosan, carrageenan, lignosulfonic acid,or their derivatives can be used. Use only compounds that are approved by the Food and Drug Administration (FDA) Office of Veterinary Medicine. 

GL27 Antimicrobial Resistance Guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance... 

The US regulates animal trials mainly through the requirement to inform the authorities before non-approved veterinary pharmaceuticals are shipped to trial sites. Depending on whether it is classified as a drug or a biologic, information must be submitted to either the FDA Center for Veterinary Medicines (CVM) or the United States Department of Agriculture (USDA) Center for Veterinary Biologies (CVB). 

New therapeutic indication +1 (human) to +3 (veterinary) 3 from approval of indication... 

Guideline for Approval No. 3 General Principles for Evaluating the Safety of Compounds Used in Food-producing Animals. Revised July 1994. US Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Veterinary Medicine, RockvUle, MD(1994). 

Although most biopharmaceuticals approved to date are intended for human use, a number of products destined for veterinary application have also come on the market. One early such example is that of recombinant bovine GH (Somatotrophin), which was approved in the USA in the early 1990s and used to increase milk yields from dairy cattle. Additional examples of approved veterinary biopharmaceuticals include a range of recombinant vaccines and an interferon-based product (Table 1.7). 

Table 1.7 Some recombinant (r) biopharmaceuticals recently approved for veterinary application in the EU...

In order to overcome environmental concerns in particular, some companies are investigating the use of engineered plant cell lines as opposed to intact transgenic plants in the context of biopharmaceutical production. One company (DowAgroSciences) gained approval in 2006 for a veterinary subunit vaccine against Newcastle disease in poultry produced by such means. 

Most FDA-approved veterinary drugs are for certain species, either food-producing or for a large target population (household pets). If veterinarian pharmaceutical companies do not perceive a sufficiently large market for a product, they will not seek FDA approval. This has left a large vacuum, or a potential market, that can be filled by compounding pharmacists. There are no FDA-approved products for exotic species due to the limited market and there are only few FDA-approved products for some of the more common species. Veterinarians need patient-specific products which pharmacists know how to prepare. Consequently, a team approach has been developed to the benefit of the veterinarian, pharmacist, and the animals. 

The cephalosporins are not widely used in veterinary medical practice due to the availability of other antibiotics that are effective against the common animal pathogens, less expensive on a treatment regimen basis, and approved for use in animals. At the... 

In the U.S., unlike most nations, some antibiotic products for mastitis therapy are available to the dairyman without a veterinary prescription. For FDA approval of an over-the-counter intramammary infusion product, it is required that adequate directions for use be written so that the layman can use the drug safely and for the purposes for which it is intended. The following antibiotics are currently approved and marketed for intramammary infusion in treatment of bovine mastitis (26) ... 

Specialized antibiotic formulations have been developed for DCT, with physicochemical properties chosen to confer prolonged retention in the mammary secretions (21,, ). Ziv ( ) has summarized the desirable kinetic and other properties of such a product. The following antibiotic formulations are presently approved by the U.S. Center for Veterinary Medicine, FDA for infusion into the dry mammary gland erythromycin (300 mg), oxytetracycline-HCl (426 mg), benzathine cloxacillin (500 mg), cephapirin benzathine (300 mg), novobiocin (400 penicillin (200,000 lU) novobiocin (400 mg), penicil-... 

The use of antibiotics at any level in animal feed is strictly regulated by the Center for Veterinary Medicine of the Food and Drug Administration, acting under the US Food, Drug and Cosmetic Act of 1938 as amended in 1958 and 1963 (7). Twelve different antibiotics are approved for use in livestock feeds ... 

The Food Drug Administration has the responsibility for the premarket clearance of all animal drugs. The 1958 food additive amendment to the Federal Food, Drug Cosmetic Act requires sponsors to demonstrate the safety of their products. The Kefauver-Harris amendment of 1962 requires the sponsors to demonstrate, in addition to safety, the efficacy of their drugs. Safety implies safety to the animal as well as to the consumers of animal products. The role of the Center for Veterinary Medicine in the premarket approval process is to establish conditions of drug use and to establish the allowable tolerances for drug residues in animal-derived food products. 

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