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ANI Pharmaceuticals Announces FDA Approval of Potassium Citrate Extended-Release Tablets USP
BAUDETTE, Minn., Jan. 16, 2020 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced it has received approval of the Company's
About this update from Ani Pharmaceuticals, Inc.
[{"type":"text","content":"BAUDETTE, Minn., Jan. 16, 2020 /PRNewswire/ -- ANI Pharmaceuticals, Inc. (\"ANI\") (Nasdaq: ANIP) today announced it has received approval of the Company's abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for Potassium Citrate Extended-Release Tablets USP, 10 mEq and 15 mEq. The current annual U.S. market for this product is approximately $75 million, according to IQVIA.\nArthur S. Przybyl, ANI's President and CEO stated, \"We are excited to receive FDA approval for this extended release drug that was successfully developed by ANI's internal formulation group. We plan to launch the drug, which will be manufactured at our Baudette, Minnesota plant, in the first quarter of this year.\" \nAbout Potassium Citrate Extended-Release Tablets USP\nPotassium Citrate Extended-Release Tablets USP are indicated for the management of renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, and uric acid lithiasis with or without calcium stones. \nFor more information, including the complete list of indications and usages, please see the Full Prescribing Information.\nAbout ANI\nANI Pharmaceuticals, Inc. (the \"Company\" or \"ANI\") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals. The Company's targeted areas of product development currently include narcotics, oncolytics (anti-cancers), hormones and steroids, and complex formulations involving extended release and combination products. For more information, please visit our website www.anipharmaceuticals.com. \nForward-Looking Statements \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, statements about price increases, the Company's future operations, products, financial position, operating results and prospects, the Company's pipeline or potential markets therefor, 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 sim...