The FINANCIAL — Health Canada, the Australian Pesticides and Veterinary Medicines Authority (APVMA) and the New Zealand Ministry for Primary Industries (NZMPI) have simultaneously approved a new use for pain relief in sheep for the veterinary drug Metacam 20mg/ml.
Boehringer Ingelheim’s Metacam 20 mg/ml (active ingredient: meloxicam) has obtained approval in Australia, Canada and New Zealand for use in the alleviation of pain and inflammation in sheep. Castration of male sheep is a common management practice in the sheep industry. Up to this point, there has been no product specifically approved to reduce the pain associated with this or other common procedures in sheep. With this new indication Boehringer Ingelheim supports animal welfare in sheep in addition to a range of other species.
Although Metacam 20mg/ml was already authorized for use in cattle, pigs and horses in many countries, this is the first approval for Metacam® 20 mg/ml in sheep worldwide. Boehringer Ingelheim’s meloxicam has already proven to be an effective drug to improve animal welfare associated with procedures such as piglet castration or calf dehorning, according to Boehringer Ingelheim.
The approval comes following a joint submission from Boehringer Ingelheim in Canada, Australia and New Zealand that saw regulatory agencies from each country participate in a collaborative review process. This is the first-ever trilateral joint drug review and simultaneous drug approval between Canada, Australia and New Zealand regulators. Efficacy, target animal safety and human food safety were all jointly reviewed by the three regulatory bodies. The regulatory agencies for each country maintained the right to determine whether a product was approved for its own market.
The joint submission and simultaneous review mark an important achievement in international regulatory cooperation. Such initiative highlights the benefits of innovative international cooperative efforts to improve animal health and safety. It means farmers will have timely access to a new non-steroidal anti-inflammatory drug for sheep, a minor species from a regulatory perspective (i.e. species seldom considered for new registrations), which will enable them to better manage their flocks.
Discussion about this post