ANI Pharmaceuticals Announces FDA Approval of Potassium Citrate Extended-Release Tablets USP
ANI Pharmaceuticals, Inc. (ANIP)
Last ani pharmaceuticals, inc. earnings: 2/27 08:30 am
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Source: PR Newswire
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.Arthur 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." About Potassium Citrate Extended-Release Tablets USPPotassium 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
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ANIP
Earnings
- 2/29/24 - Beat
ANIP
Sec Filings
- 4/22/24 - Form 4
- 4/19/24 - Form 144
- 4/18/24 - Form 144
- ANIP's page on the SEC website