Mizner Bioscience LLC reported on Wednesday the receipt of the first approval for a therapeutically equivalent generic version of Clomipramine Hydrochloride Tablets from the US Food and Drug Administration's (FDA) Abbreviated New Animal Drug Application (ANADA) pathway.
Clomipramine Hydrochloride Tablets are used as part of a comprehensive behavioural management programme to treat separation anxiety in dogs over six months of age.
Following the FDA's approval, the company will launch its Clomipramine Hydrochloride Tablets in 5mg, 20mg, 40mg and 80mg with immediate effect.
According to the company, the tablet is the equivalent generic version of Elanco's Clomicalm (Clomipramine Hydrochloride Tablets).
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