(RTTNews) - ANI Pharmaceuticals, Inc. (ANIP), a biopharmaceutical company, on Thursday announced that the U.S. Food and Drug Administration has approved its Abbreviated New Drug Application for Prucalopride Tablets, the generic version of Motegrity.
Motegrity is a medication used to treat chronic idiopathic constipation (CIC) in adults.
The FDA has granted Competitive Generic Therapy (CGT) designation to the company's Prucalopride, providing it with 180-day exclusivity.
Nikhil Lalwani, President and CEO of ANI, stated, "We are delighted to build momentum early in 2025 with the approval of the first generic for Motegrity, once again highlighting our superior R&D capabilities." ANI Pharmaceuticals is proud to hold the second-highest number of CGT approvals in the U.S. generics market.
ANIP closed Tuesday's (Dec. 31, 2024) trading at $55.28, up 1.97%. In premarket trading, the stock is up 0.13% at $55.35.
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