FDA approves ANI's potassium citrate ANDA

Potassium citrate extended-release tablets have been indicated for the management of calcium-related diseases

ANI Pharmaceuticals has received approval for its abbreviated new drug application (ANDA) from the FDA. The ANDA is for ANI’s Potassium Citrate Extended-Release Tablets USP, both 10 milliequivalent (mEq) and 15 mEq.

Arthur 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."

The current annual US market for this product is approximately $75 million, according to IQVIA.


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.