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U.S. Department of Health and Human Services

Animal & Veterinary

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SUPPLEMENTAL NEW ANIMAL DRUG APPROVALS - November/December 2002

FDA Veterinarian Newsletter 2002 Volume XVI, No VI

Company
Generic and (Brand) Names
Indications
Routes/Remarks

Pharmacia and Upjohn Co.
(NADA 135-940)
(NADA 120-161)

Clindamycin Hydrochloride (Antirobe Aquadrops Liquid RX, Antirobe Capsules RX)

Dogs and Cats. For the treatment of bacterial skin infections and bacterial soft tissue infections.

ORAL - The supplement to NADA 135-940 for an oral liquid provides for an expanded dose range for the use of clindamycin hydrochloride in both dogs and cats for the treatment of certain bacterial infections. The supplement to NADA 120-161 for oral capsules provides for an expanded dose range in dogs and cats and for use of a 300 mg strength capsule. Infections treatable are caused by susceptible strains of coagulase-positive staphylococci such as S. aureus.
Federal Register 08/27/02

Fort Dodge Animal Health Div. of American Home Products Corp.
(NADA 141-189)

Moxidectin, ProHeart® 6 Sustained Release Injectable RX

Dogs. For the treatment of existing hookworm infections.

SUBCUTANEOUS or INTRAMUSCULAR - The supplement provides for veterinary prescription use of a sustained-release injectable moxidectin formulation for treatment of existing larval and adult hookworm (U. stenocephala) infections.
Federal Register 09/13/02

Pfizer, Inc.
(NADA 141-053)

Carprofen (Rimadyl®) RX

Dogs. For control of postoperative pain associated with soft tissue and orthopedic surgery.

ORAL - The supplement provides for the veterinary prescription use of carprofen oral caplets in dogs.
Federal Register 10/23/02

Pfizer, Inc.
(NADA 141-111)

Carprofen (Rimadyl®) RX

Dogs. For the control of postoperative pain associated with soft tissue and orthopedic surgery.

ORAL - The supplement provides for the veterinary prescription use of carprofen in dogs, by oral chewable tablet.
Federal Register 10/28/02