FDA Approves First Generic Spectinomycin Sulfate Injectable for Treatment of Bovine Respiratory Disease

Oct. 17, 2022

September 29, 2022

Today the U.S. Food and Drug Administration approved SpectoGard, the first generic spectinomycin sulfate injectable solution for the treatment of bovine respiratory disease (pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.

SpectoGard contains the same active ingredient (spectinomycin sulfate) in the same concentration and dosage form as the approved brand name drug product, Adspec, which was first approved on January 28, 1998.

SpectoGard is only available by prescription because a veterinarian’s expertise is required to determine if SpectoGard is an appropriate treatment for cattle.

Allergic reactions may occur in previously sensitized individuals. Repeated or prolonged exposure may lead to sensitization. Direct contact with skin, eyes, mouth, and clothing should be avoided. People with a known hypersensitivity to spectinomycin should avoid exposure to this product.

SpectoGard is supplied in 500mL vials and should be administered to cattle at a daily dose of 10 to 15 mg spectinomycin per kg of body weight (4.5 to 6.8 mL per 100 lb body weight). Treatment should be administered at 24-hour intervals for 3 to 5 consecutive days.

SpectoGard is sponsored by Bimeda Animal Health Ltd, based in Dublin, Ireland.

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Source from FDA

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