ANI Pharmaceuticals 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.
"We are excited to receive FDA approval for this extended release drug that was successfully developed by ANI's internal formulation group,” Arthur S. Przybyl, ANI's President and CEO said. “We plan to launch the drug, which will be manufactured at our Baudette, Minnesota plant, in the first quarter of this year."
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Potassium 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.