ANI Pharma (ANIP) Announces FDA Approval and Imminent Launch of Clorazepate Dipotassium Tablets USP

Go back to ANI Pharma (ANIP) Announces FDA Approval and Imminent Launch of Clorazepate Dipotassium Tablets USP

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

June 22, 2022 6:50 AM EDT

BAUDETTE, Minn.--(BUSINESS WIRE)-- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that the Company received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Clorazepate Dipotassium Tablets.

ANIs 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... More