New Animal Drug Approvals

Company

Merck Research Labs., Division of Merck & Co., Inc. (NADA 141-054)

Generic and (Brand) Names

Ivermectin (Ivomec®) and Lincomycin (Lincomix®)

Indications

Swine. For treatment and control of certain helminth, lice, and mite infections; increased rate of weight gain; treatment and control of swine dysentery; and reduction of severity of swine mycoplasma pneumonia in growing-finishing swine.

Routes/Remarks

MEDICATED FEED: Provides for ivermectin 0.6 percent Type A medicated article and lincomycin 20 and 50 grams per pound Type A medicated articles to make ivermectin/lincomycin Type B and C medicated feeds. The Type C medicated swine feeds contain 1.8 grams ivermectin with 20, 40, 100, or 200 grams lincomycin. Federal Register 6/25/96.

Company

Upjohn Co. (NADA 140-890)

Generic and (Brand) Names

Ceftiofur Hydrochloride Sterile Suspension (Excenel® Sterile Suspension) Rx

Indications

Swine. For treatment and control of certain forms of swine bacterial respiratory disease.

Routes/Remarks

INJECTABLE: Provides for ceftiofur hydrochloride equivalent to 50 milligrams per milliliter ceftiofur. Federal Register 6/11/96.

Company

Pfizer, Inc. (NADA 140-058)

Generic and (Brand) Names

Semduramicin with Bacitracin Methylene Disalicylate and Roxarsone

Indications

Broiler Chickens. For prevention of coccidiosis and for improved feed efficiency.

Routes/Remarks

MEDICATED FEED: Provides for combining approved Type A medicated articles containing Aviax ® (semduramicin sodium) with BMD ® (bacitracin methylene disalicylate) and 3-Ntiro ® (roxarsone) to make combination drug Type C medicated feed containing 22.7 grams of semduramicin, 10 to 50 grams of bacitracin methylene disalicylate, and 45.4 grams of roxarsone per ton. Federal Register 6/11/96.

Abbreviated New Animal Drug Approvals

Company

Lambert-Kay, Div. of Carter-Wallace, Inc. (ANADA 200-028)

Generic and (Brand) Names

Pyrantel Pamoate Suspension

Indications

Dogs. For removal of large roundworms and hookworms in puppies and dogs and to prevent reinfection of Toxocara canis in puppies, adult dogs, and in lactating bitches after whelping.

Routes/Remarks

ORAL: Product containing pyrantel pamoate equivalent to 2.27 milligrams of pyrantel base. ANADA 200-028 is a generic copy of Pfizer's NADA 100-237, Nemex(TM) . Federal Register 6/11/96.

Company

Phoenix Scientific, Inc. (ANADA 200-162)

Generic and (Brand) Names

Tripelennamine hydrochloride Injection Rx

Indications

Cattle and Horses. For conditions in which antihistamine therapy may be expected to lead to alleviation of some signs of disease.

Routes/Remarks

INJECTABLE: ANADA 200-162 is a generic copy of Solvay's NADA 006-417 for Re-Covr ® Injection. Federal Register 6/11/96.

Company

Wade Jones Co., Inc. (ANADA 200-130)

Generic and (Brand) Names

Neomycin sulfate soluble powder

Indications

Cattle (excluding veal calves), swine, sheep, and goats. For treatment and control of bacterial enteritis.

Routes/Remarks

ORAL: ANADA 200-130 is a generic copy of Upjohn's NADA 11-315. Federal Register 6/19/96.

Company

Pennfield Oil Co. (ANADA 200-154)

Generic and (Brand) Names

Oxytetracycline Injection

Indications

Beef cattle, non-lactating dairy cattle, and swine. Used in beef cattle and non-lactating dairy cattle for treatment of pneumonia and shipping fever complex, infectious bovine keratoconjunctivitis, foot rot and diphtheria, bacterial enteritis, wooden tongue, leptospirosis, wound infections, and metritis. Used in swine for treatment of bacterial enteritis, pneumonia, leptospirosis, and in sows as an aid in the control of enteritis (baby pig scours and colibacillosis) in suckling pigs.

Routes/Remarks

INJECTABLE: ANADA 200-154 is a generic copy of Pfizer's NADA 113-232 (Liquamycin ® LA-200). Federal Register 6/19/96.

Company

Upjohn Co. (ANADA 200-127)

Generic and (Brand) Names

Spectinomycin Injection

Indications

Turkey Poults and Newly Hatched Chicks. As an aid in the control of bacterial respiratory infections, airsacculitis, and mortality.

Routes/Remarks

INJECTABLE: ANADA 200-127 is a generic copy of Rhone Merieux's (formerly Sanofi Animal Health) NADA 040-040 (Spectam ® Injectable). The regulations are also amended to add a tolerance for spectinomycin residues in turkey tissues. Federal Register 6/19/96.

Company

Rhone Merieux, Inc. (ANADA 200-153)

Generic and (Brand) Names

Neomycin sulfate oral solution

Indications

Cattle (excluding veal calves), swine, sheep, and goats. For treatment and control of bacterial scours.

Routes/Remarks

ORAL: ANADA 200-153 is a generic copy of Upjohn's NADA 11-315. Federal Register 6/20/96.

Company

Intervet, Inc. (ANADA 200-134)

Generic and (Brand) Names

Gonadorelin Diacetate Tetrahydrate (Fertagyl ®) Injection

Indications

Female Dairy Cattle of Breeding Age. For treatment of ovarian cysts.

Routes/Remarks

INJECTABLE: ANADA 200-134 is a generic copy of Rhone Merieux's NADA 98-379 (Cystorelin ®). Federal Register 7/19/96.

Abbreviated Supplemental New Animal Drug Approvals

Company

Boehringer Ingelheim Animal Health, Inc. (ANADA 200-008)

Generic and (Brand) Names

Oxytetracycline injection (OXY-TET 200/BIO- MYCIN 200)

Indications

Beef and Non-lactating Dairy Cattle. For treatment of diseases caused by oxytetracycline susceptible organisms.

Routes/Remarks

INJECTABLE: Administer intramuscularly, intravenously, or subcutaneously at 3 to 5 milligram level, intramuscularly or subcutaneously at 9 milligram level. Federal Register 7/10/96.

Supplemental New Animal Drug Approvals

Company

Merck Research Labs. (Division of Merck & Co., Inc.) (NADAs 138-142 and 140-886)

Generic and (Brand) Names

Ivermectin (Heartgard) ® Tablets and Chewable Cubes Rx

Indications

Dogs. To prevent canine heartworm disease

Routes/Remarks

ORAL: The supplemental NADAs amend the approved indications for use to read "To prevent canine heartworm disease by eliminating the tissue stage of heartworm larvae for 1 month also amend the limitations pertaining to puppies to state "Recommended for dogs 6 weeks of age and older." Federal Register 7/31/96.

Company

Hoffman LaRoche, Inc. (NADA 48-761)

Generic and (Brand) Names

Chlortetracycline (Aureomycin) ®

Indications

Grazing Beef Cattle, weighing over 700 pounds. For control of active anaplasmosis infections.

Routes/Remarks

MEDICATED FEED: Provides for use of a free-choice mineral, Type C cattle feed containing 4 grams/lb. chlortetracycline. Federal Register 7/10/96.

Company

Hoffman La Roche, Inc. (NADA 48-761) (formerly held by American Cyanamid); Pfizer, Inc. (NADA 92-286 and NADA 92- 287); ALPHARMA (formerly A.L. Labs.) (NADA 46-699); ADM Animal Health & Nutrition Division (formerly Feed Specialties Co.) (NADA 48-480); PennField Oil Co. (NADA 138-935)

Generic and (Brand) Names

Chlortetracycline

Indications

Chickens, Turkeys, Swine, Sheep, Calves, Beef and Non- Lactating Dairy Cattle. For improved production efficiency, and for control and treatment of certain bacterial diseases susceptible to chlortetracycline.

Routes/Remarks

MEDICATED FEED: Provides for safe and effective use of Type A medicated articles containing chlortetracycline in the feed. Approvals reflect compliance with results of the NAS/NRC DESI evaluation of the drug's effectiveness and FDA's conclusions concerning that evaluation. Federal Register 7/9/96.

Company

Upjohn Co. (NADA 140-338)

Generic and (Brand) Names

Ceftiofur (Naxcel ® Sterile Powder) for Injection

Indications

Day-old Chicks and Day-Old. Turkey Poults. For control of mortality associated with E. coli organisms susceptible to ceftiofur.

Routes/Remarks

INJECTABLE: Provides for use of 0.08 to 0.20 per chick and 0.17 to 0.5 milligrams per poult. Federal Register 7/5/96.

Company

Upjohn Co. Agricultural Division (NADA 11-315); Pfizer, Inc. (ANADA 200-046); and Rhone Merieux, Inc. (ANADA 200-050)

Generic and (Brand) Names

Neomycin Sulfate Soluble Powder in Drinking Water or Milk

Indications

Cattle (excluding veal calves), swine, sheep, and goats. For treatment and control of bacterial scours.

Routes/Remarks

ORAL: The supplements provide for revised preslaughter withdrawal times following use of the drug and revised tolerances for neomycin residues in edible tissues of treated animals. Federal Register 6/20/96.

Company

Pfizer, Inc. (NADA 140-998)

Generic and (Brand) Names

Virginiamycin

Indications

Cattle fed in confinement for slaughter. For improved feed efficiency, for reduction of incidence of liver abscesses, and for increased rate of weight gain.

Routes/Remarks

MEDICATED FEED: Provides for 30 percent virginiamycin Type A medicated article formulation to be used in micro- ingredient production process for the preparation of Type C medicated feeds. Federal Register 6/14/96.

Company

Bayer Corp., Agriculture Div., Animal Health Products (NADA 141-007)

Generic and (Brand) Names

Praziquantel, Pyrantel Pamoate,and Febantel (Drontal Plus (TM)) Tablets Rx

Indications

Dogs. For removal and control of the tapeworm Echinococcus multilocularis.

Routes/Remarks

ORAL: Provides for oral prescription use of Drontal Plus(TM) tablets for small dogs containing 22.7 milligrams each praziquantel and pyrantel base (as pyrantel pamoate), and 113.4 milligrams febantel, and Drontal Plus(TM) tablets for medium and large containing 68 milligrams each praziquantel and pyrantel pamoate), and 340.2 milligrams febantel. Federal Register 6/12/96.

Company

Roussel UCLAF, Division of Agro-Veterinaire, Paris, France (NADA 140-897)

Generic and (Brand) Names

Trenbolone acetate and estradiol

Indications

Pasture Steers (slaughter, stocker, and feeder) for increased rate of weight gain.

Routes/Remarks

IMPLANT: Provides for use of an ear implant containing 2 pellets, each pellet containing 20 milligrams of trenbolone acetate, and 4 milligrams of estradiol. Federal Register 6/11/96.

Company

Hoechst-Roussel Agri- Vet Co. (NADAs 128-620, 132-872, and 137-600)

Generic and (Brand) Names

Fenbendazole

Indications

Beef and Dairy Cattle. For the removal and control of gastro-intestinal parasites and lungworms.

Routes/Remarks

For NADA 128-620, 10 percent suspension; for NADA 132-872 for 10 percent paste; and for NADA 137-600 for 20 percent Type A medicated article, 0.5 percent pelleted top dressing, and 35 percent free-choice mineral feed. The original NADA was for beef and dairy cattle not of breeding age. The supplement expands the use to include use in dairy cattle of breeding age. Also, it provides for establishment of safe concentration and tolerance for fenbendazole residues in milk of treated dairy cattle and no requirement for discard of milk from the animals. Federal Register 6/11/96.