FDA approves abbreviated new drug application for oral anxiety treatment

ANI Pharmaceuticals Inc. has received FDA approval of its abbreviated new drug application for clorazepate dipotassium tablets, according to a company press release.

ANI stated that this is a generic version of Tranxene (clorazepate dipotassium, Sanofi), which is indicated for managing anxiety disorders, according to the FDA package insert.

"We continue to strengthen our base business with new product launches,” ANI President and CEO Nikhil Lalwani, said in the release. “The imminent launch and commercialization of clorazepate dipotassium tablets is another example of our ongoing commitment to ensuring that patients in need have access to important therapeutics.”