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).
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial