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U.S. Department of Health and Human Services

Animal & Veterinary

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Approvals for August and September 2007

FDA Veterinarian Newsletter 2007 Volume XXII, No IV

CVM has published in the Federal Register notice of the approval of these New Animal Drug Applications (NADAs)

  • PROFENDER (emodepside and praziquantel) Topical Solution (NADA 141-275), filed by Bayer HealthCare LLC. The NADA provides for the use of PROFENDER (emodepside and praziquantel) Topical Solution for the treatment and control of infections caused by several internal parasites in cats. Notice of approval was published August 2, 2007.

CVM has published in the Federal Register notice of the approval of these Abbreviated New Animal Drug Applications (ANADAs)

  • AMPICILLIN SODIUM POWDER (ANADA 200-335), filed by G.C. Hanford Manufacturing Co. The ANADA provides for the use of ampicillin sodium as a constituted solution by injection in horses for the treatment of various bacterial infections, including respiratory, skin, and soft tissue infections. The product was approved as a generic copy of Pfizer’s AMP-EQUINE, approved under NADA 55-084. Notice of the ANADA approval was published August 13, 2007.
  • FORMACIDE-B (formalin) (ANADA 200-414), filed by B.L. Mitchell, Inc. The ANADA provides for the use of FORMACIDE-B (formalin) in a water bath for the control of certain external parasites on finfish and shrimp and for the control of certain fungi on finfish eggs. The product is approved as a generic copy of Parasite-S, sponsored by Western Chemical, Inc., under NADA 140-989. Notice of approval was published August 13, 2007.
  • OXYTET 10 (oxytetracycline hydrochloride) Injection (ANADA 200-452), filed by Norbrook Laboratories, Ltd. The ANADA provides for the use of OXYTET 10 (oxytetracycline hydrochloride) Injection in beef cattle, beef calves, nonlactating dairy cattle, and dairy calves for the treatment of various bacterial diseases. Norbrook Laboratories’ OXYTET 10 Injection is approved as a generic copy of Boehringer Ingelheim Vetmedica’s MEDAMYCIN Injectable, approved under NADA 108-963. Notice of approval was published August 2, 2007.