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ANI Pharma : FDA Okays Potassium Citrate Extended-Release Tablets USP

ANI Pharmaceuticals Inc. (ANIP) said it has received approval of the company's abbreviated new drug application from the U.S. Food and Drug Administration 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.

The company plans to launch the drug in the first quarter of this year.

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.

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