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ANI Pharmaceuticals Announces FDA Approval and Imminent Launch of Clorazepate Dipotassium Tablets USP
BAUDETTE, Minn.--(BUSINESS WIRE)-- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that the Company received U.S. Food and Drug
About this update from Ani Pharmaceuticals, Inc.
[{"type":"text","content":" BAUDETTE, Minn.--(BUSINESS WIRE)--\nANI 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.\n\nANI’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.\n\n\"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.\n\nAbout ANI\n\nANI Pharmaceuticals, Inc. is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. Our team is focused on delivering sustainable growth by building a successful Purified Cortrophin® Gel franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities. For more information, please visit our website www.anipharmaceuticals.com.\n\nForward-Looking Statements\n\nTo the extent any statements made in this release deal with information that is not historical, these are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, those relating to the launch and commercialization and potential sales of Clorazepate Dipotassium Tablets and any additional product launches from the Company’s generic pipeline and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “plans,” “potential,” “future,” “believes,” “intends,” “continue,” other words of similar meaning, derivations of such words and the use of future dates.\n\nUncertainties and risks may cause the Company’s actual resu...