ANI gets FDA OK for potassium citrate

ANI Pharmaceuticals has obtained the Food and Drug Administration’s blessing for potassium citrate extended-release tablets in dosage strengths of 10 mEq and 15 mEq. 

"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," said Arthur Przybyl, ANI's president and CEO.

Potassium citrate extended-release tablets 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.

The product has a market value of approximately $75 million, according to IQVIA.