logo
Plus   Neg
Share
Email

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
India-based Lupin Pharmaceuticals Inc. announced a recall of all batches of type 2 diabetes medication Metformin Hydrochloride Extended-Release Tablets, citing detection of N-Nitrosodimethylamine or NDMA, a probable human carcinogen. The move comes after many other drug companies called back Metformin tablets after the U.S. Food and Drug Administration or FDA recommended over NDMA concerns. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said that the current state of the COVID-19 pandemic in the U.S. is "really not good." The U.S. is the country worst-affected by the coronavirus and has recently seen a surge in coronavirus infections as lockdown restrictions are eased. Granules Pharmaceuticals, Inc. recalled twelve (12) lots of type 2 diabetes medication Metformin hydrochloride Extended-Release, in the form of oral film-coated tablets, for the potential presence of nitrosamine impurity, N-Nitrosodimethylamine (NDMA), above levels of the Acceptable Daily Intake Limit (ADI), the U.S. Food and Drug Administration or FDA said in a statement.
Follow RTT