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NEW ANIMAL DRUG APPROVALS Company Pfizer, Inc. Generic and (Brand) Names Atipamezole hydrochloride (Antisedan®)Rx Indications Dogs. For use as a medetomidine reversing agent. Routes/Remarks INJECTABLE: Each milliliter of sterile injectable solution contains 5.0 milligrams
of atipamezole hydrochloride. Company Schering-Plough Animal Health Generic and (Brand) Names Florfenicol Solution (Nuflor®) Rx Indications Cattle. For treatment of bovine respiratory disease. Routes/Remarks INJECTABLE: Each milliliter of sterile injectable solution contains 300 milligrams
of florfenicol. ABBREVIATED NEW ANIMAL DRUG APPROVALS Company Med-Pharmex, Inc. Generic and (Brand) Names Gentamicin sulfate and betamethasone valerate otic solution Rx. Indications Dogs and Cats. For treatment of acute and chronic canine otitis externa and canine and feline superficial infected lesions caused by bacteria sensitive to gentamicin. Routes/Remarks TOPICAL: Each cubic centimeter of solution contains gentamicin sulfate equivalent
to 3 milligrams gentamicin and betamethasone valerate equivalent to 1 milligram
betamethasone. This ANADA is a generic copy of Schering Plough¹s NADA 46-821
for Gentocin Otic Solution.
Company Chanelle Pharmaceuticals Manufacturing Ltd., Galway, Ireland Generic and (Brand) Names Xylazine (Chanazine®) Rx Indications Dogs and Cats. To produce sedation accompanied by a shorter period of analgesia. Routes/Remarks INJECTABLE: ANADA 200-184 is a generic copy of Bayer¹s NADA 47-955 for
Rompun® Injection. SUPPLEMENTAL NEW ANIMAL DRUG APPROVALS Company Pfizer, Inc. Generic and (Brand) Names Oxytetracycline Type A Medicated Articles Indications Bovine, ovine, porcine, and avian (chickens and turkeys). For increased rate of weight gain, improved feed efficiency, and control and treatment of certain bacterial diseases susceptible to oxytetracycline (OTC). Honeybees: control of certain foulbrood diseases susceptible to OTC. Routes/Remarks MEDICATED FEED: The supplemental NADA provides revised labeling for Pfizer¹s
pioneer, Type A, oxytetracycline-containing medicated articles which brings
the products into compliance with the findings of the NAS/NRC Drug Efficacy
Study Group¹s effectiveness evaluation and subsequent FDA conclusions.
In addition, the regulations are further amended to reflect approval, based
on FDA¹s DESI ³me-too² policy, of one original NADA each filed
by Pfizer (95-143) and PennField Oil Co. (138-938) for Type A medicated articles
that are copies of the Pfizer pioneer products. Company Elanco Animal Health, Division of Eli Lilly and Co. Generic and (Brand) Names Monensin Indications Pasture Cattle weighing less than 400 pounds. For increased rate of weight gain. Routes/Remarks MEDICATED FEED: The existing NADA provides for use of a Type A medicated article
to make a monensin, Type C, medicated feed/free-choice mineral granule containing
1620 grams monensin per ton to be fed at 50 to 200 milligrams per head per day
free-choice to pasture cattle. The supplemental NADA provides for removal of
the restriction concerning use of the product for animals weighing less than
400 pounds body weight.
Company Pfizer, Inc. Generic and (Brand) Names Sulfadimethoxine/Ormetoprim (Primor®)Rx tablets. Indications Dogs. The existing NADA provides for treatment of certain bacterial skin and soft tissue infections (wounds and abscesses). The supplement adds the treatment of certain bacterial urinary tract infections. Routes/Remarks ORAL. Company Roussel-UCLAF, Division of Agro-Veterinaire Generic and (Brand) Names Trenbolone Acetate and Estradiol (Revalor®-G) Indications Pasture Heifers (in addition to a previously approved use in pasture steers). For increased rate of weight gain. Routes/Remarks IMPLANT: Provides for use of Revalor®-G, an ear implant, each dose containing
2 pellets, each pellet containing 20 milligrams of trenbolone acetate and 4
milligrams of estradiol.
prev | next Source: November/December 1996 FDA Veterinarian Newsletter |
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