Pharma Focus Asia

ANI Pharmaceuticals Announces FDA Approval and Imminent Launch of Clorazepate Dipotassium Tablets USP

Thursday, June 23, 2022

ANI Pharmaceuticals, Inc., announced that the Company received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Clorazepate Dipotassium Tablets.

ANI’s Clorazepate Dipotassium Tablets are the generic version of the Reference Listed Drug (RLD) Tranxene®. The current annual U.S. market for Clorazepate Dipotassium Tablets is approximately $25.8 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

"We continue to strengthen our base business with new product launches. 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,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

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