ANI Pharma Receives FDA Approval For ANDA, Launches Naproxen Delayed-Release Tablets

(RTTNews) - Tuesday, ANI Pharmaceuticals, Inc. (ANIP) announced that it received approval from the U.S. Food and Drug Administration for the Abbreviated New Drug Application or ANDA and launched Naproxen Delayed-Release Tablets, USP.

The company also stated that its Naproxen Delayed-Release Tablets, a nonsteroidal anti-inflammatory drug used to relieve mild to moderate pain and inflammation, is the generic version of the reference-listed drug, EC-Naprosyn.

According to IQVIA data from April 2024, U.S. annual sales for Naproxen Delayed-Release Tablets amount to around $36.7 million.

ANIP's stock on the Nasdaq closed at $63.44, down 0.38% on July 1.