WASHINGTON (dpa-AFX) - ANI Pharmaceuticals, Inc. (ANIP) announced Thursday the launch of Prucalopride Tablets, which is the generic version of the reference listed drug (RLD) Motegrity.
The launch follows the final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA)
The FDA has granted Prucalopride Tablets a Competitive Generic Therapy (CGT) designation, with 180-day exclusivity.
U.S. annual sales for Prucalopride Tablets total approximately $168.0 million, based on October 2024 moving annual total (MAT) IQVIA data.
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