FDA, Health Canada simultaneously review mastitis drug

FDA and Health Canada conduct simultaneous review and approval of veterinary drug for use in food-producing animals.

The U.S. Food & Drug Administration, in cooperation with Health Canada, announced the simultaneous approval of Elanco Animal Health's Imrestor (pegbovigrastim injection), a new animal drug intended to reduce the incidence of clinical mastitis of dairy cows and replacement dairy heifers.

According to the agencies, this is the fourth animal drug approved under collaborative initiative with Canada but the first animal drug to be simultaneously reviewed and approved for use in food

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